Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Occupational exposure to product, Skin laceration, Syringe issue
Clinical narrative: The syringe crashed into nurse's finger and cut it; The syringe crashed into nurse's finger and cut it; This spontaneous case from the was received on 13-Oct-2020 from other health professional (nurse) via The Agency (reference number SEQW20-03501) and additional information received on the same day from Product Technical Complaint (PTC) group and concerned a 54-year-old, female nurse.  The patient had no relevant medical history and was not taking any concomitant medications.   On 13-Oct-2020, after the nurse injecting the syringe into patient's arm and after administering the patient with Afluria Quadrivalent (influenza vaccine), the syringe crashed into nurse's finger and cut it (explicitly coded as 'syringe broke'). The full dose was administered to the patient. The device associated with Afluria Quadrivalent was luer lok. The batch number reported was P100230205 and expiry date was 30-Jun-2021.   On the same day, the nurse recovered from the event 'laceration of finger'.  The reporter did not provide a causality assessment to Afluria Quadrivalent. The reporter assessed the events as related to device luer lok.   The reporter assessed the case as non-serious.  It was reported that the defect was discovered during administration. The glass from syringe was damaged. There was no any sign of leakage. The product was stored in fridge and cooler and there were no box or packaging damage.  This case has been entered onto manufacturing quality assurance tracking database and allocated reference number 1068182.  An investigation into batch P100230205 revealed the most probable root cause of broken finger flange on 2 syringes in Afluria_P100230205 in the 2020/2021 campaign was due to packaging equipment at the fill/finish facility. Shipping of the product was also a possible root cause for the event, as it could not be completely ruled out. Since the packaging line was the most likely root cause, the root cause has been assigned as 'Equipment Malfunction' and the complaint was justified. It was concluded that there was no requirement for any market action based on all information received, as there was no patient safety risk and the overall defect rate for broken finger flanges is 1 Defect/Million Syringes distributed. No additional actions are required for Afluria PFS Drug Product or for batch P100230205.  Additional information was received on 26-Nov-2020 from manufacturing quality assurance department: Quality Assurance Investigation Results were provided. Narrative was amended accordingly.  Company comment: Reportedly, after the nurse injecting the syringe into patient's arm and after administering the patient with Afluria Quadrivalent, the syringe crashed into nurse's finger and cut it (explicitly coded as 'syringe broke'). The event of skin laceration occurred due to syringe issue, making causal relationship not related to Afluria Quadrivalemt. Causality for syringe issue is also assessed as not related per company's conventions. 'Syringe broke' and 'laceration of finger' are assessed as related to device luer lok.; Sender's Comments: Reportedly, after the nurse injecting the syringe into patient's arm and after administering the patient with Afluria Quadrivalent, the syringe crashed into nurse's finger and cut it (explicitly coded as 'syringe broke'). The event of skin laceration occurred due to syringe issue, making causal relationship not related to Afluria Quadrivalemt. Causality for syringe issue is also assessed as not related per company's conventions. 'Syringe broke' and 'laceration of finger' are assessed as related to device luer lok.