Received Jun 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | Y012507 | — |
The HCP then inspected the syringe and stated the needle just popped off as if there was built up pressure and fell on the bed.; No additional AE; the dose sprayed or oozed out from below where the needle screws on at (exact location unknown).; While administering the injection to the patient the medication immediately spray out. When the injection was withdrawn, the entire needle popped out of the syringe and landed on the bed; This Spontaneous report was received from Other health professional and referred to a/an 7-days-old ( Race Unknown ) ( Ethnicity Unknown) Neonate patient of unknown gender. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On 13-Apr-2026, the patient started therapy with Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 (Batch/Lot Number: Y012507) (Expiration date: 08-Dec-2026). The patient started therapy with Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 for the treatment of Prophylaxis, On 13-Apr-2026, the patient experienced While administering the injection to the patient the medication immediately spray out. When the injection was withdrawn, the entire needle popped out of the syringe and landed on the bed (Poor quality device used). On 13-Apr-2026, the patient experienced the dose sprayed or oozed out from below where the needle screws on at (exact location unknown). (Device leakage). On an unknown date, the patient experienced The HCP then inspected the syringe and stated the needle just popped off as if there was built up pressure and fell on the bed. (Device connection issue). On an unknown date, the patient experienced No additional AE (No adverse event). The Outcome of Poor quality device used was not provided. The Outcome of Device leakage was not provided. The Outcome of Device connection issue was not provided. The Outcome of No adverse event was not provided. The action taken with Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 regarding Poor quality device used was Not applicable with Not Applicable dechallenge and rechallenge results. Case Assessments: Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 regarding Device leakage with Not Applicable dechallenge and rechallenge results. Case Assessments: Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 regarding Device connection issue with Not Applicable dechallenge and rechallenge results. Case Assessments: Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 regarding No adverse event with Not Applicable dechallenge and rechallenge results. The Other health professional considered the event Poor quality device used (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093, the event Device leakage (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093, the event Device connection issue (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093, and the event No adverse event (,) to be not assessed to Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 The Other health professional considered the event Poor quality device used to be non-serious, the event Device connection issue to be non-serious, the event No adverse event to be non-serious, and the event Device leakage to be non-serious The following updates were made to the case on 10-Jun-2026: Details of the adverse event Poor quality device used were updated, including event (llt). Details of the adverse event Leak at device connection were updated, including event (llt). The reported product Hepatitis B Vaccine (Recombinant), 5 mcg/0.5mL Suspension for injection 64457246:4093 updated from a Drug Not Administered product to a Suspect product. The reported product SYRINGE (GLASS) 1.5ML LL updated from a Drug Not Administered product to a Suspect product.