Report #2825633

Overview

Sex

Unknown

Age

Age unknown

State

NJ

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

It cracked when drawing it from the vial, the diluent tip cracked; This is a spontaneous report received from an Other HCP from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LL8391, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "It cracked when drawing it from the vial, the diluent tip cracked". Causality for "it cracked when drawing it from the vial, the diluent tip cracked" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: While drawing it up the tip cracked instantly. Normally this does not happen. It cracked when drawing it from the vial, the diluent tip cracked. NDC: 0069-0344-01. Abrysvo Vial Adapter: Lot number: J591, expiration date: 29Nov2028. Abrysvo Diluent Syringe: Lot number: HT4720, expiration date: Dec2026. NDC: 0069-0250-01. A sample of the product is available to be returned.