Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Syringe issue, Wound
Clinical narrative: While she was pushing the plunger it broke as well as the glass of the syringe and the small glasses cut three of the Pharmacy Technician's fingers; While she was pushing the plunger it broke as well as the glass of the syringe and the small glasses cut three of the Pharmacy Technician's fingers; This spontaneous case was received on 18-Nov-2022 from pharmacist (reference number: SEQW22-05930) with additional information (being processed together), received from quality assurance department (reference number: 1113635), on 23-Nov-2022, and concerned a 47-year-old, female patient.  The patient's medical history and concomitant medications were not reported.   On 17-Nov-2022, the patient was vaccinated with prefilled syringe of Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. During the vaccination, while pushing the plunger it broke, as well as the glass of the syringe (explicitly coded as ' Syringe broken'). The device associated with Flucelvax Quadrivalent was Luer Lok syringe. The batch number reported was 942395, expiration date was 18-Jun-2023. The pharmacist stated that when Pharmacy technician was administrating the Flucelvax, and while was pushing the plunger it broke as well as the glass of the syringe and the small glasses cut three of the Pharmacy Technician's fingers. The pharmacist transferred the call to the Pharmacy Technician so that could better explain what happened, as it was her that everything happened. The Pharmacy Technician stated that had no difficulty in fully depressing the plunger, that was that there was no resistance in pushing the plunger. The plunger only broke at the end after she had funny depressed it and so she was able to give the full dose to the patient. When the syringe broke, the glasses only hit the Pharmacy Technician's fingers and therefore the patient did not suffer any injuries At the time of the initial report, the patient had not recovered from the event of 'cut wound'.  The reporter did not provide a causality assessment.  This case has been entered onto quality assurance tracking database and allocated reference number 1113635.  The case was assessed as non-serious.  Company comment: A 47-year-old female patient was vaccinated with the suspect Flucelvax Quadrivalent vaccine. Reportedly, during vaccination while pushing the plunger, it broke as well as glass of the syringe (explicitly coded as 'Syringe broken') and resulted in cut wound of the technician's fingers. Information regarding the underlying medical history and concomitant medications has not been provided. Causality for the event of cut wound is assessed as not related to the suspect vaccine, considering it occurred as result of broken syringe. Causality for syringe broken is assessed as not related to the suspect vaccine, as per the Company specific guidelines. Both events are related to the Luer Lok syringe.; Sender's Comments: A 47-year-old female patient was vaccinated with the suspect Flucelvax Quadrivalent vaccine. Reportedly, during vaccination while pushing the plunger, it broke as well as glass of the syringe (explicitly coded as 'Syringe broken') and resulted in cut wound of the technician's fingers. Information regarding the underlying medical history and concomitant medications has not been provided. Causality for the event of cut wound is assessed as not related to the suspect vaccine, considering it occurred as result of broken syringe. Causality for syringe broken is assessed as not related to the suspect vaccine, as per the Company specific guidelines. Both events are related to the Luer Lok syringe.