Sex: F
Vaccine: FLU4
Symptoms: Product quality issue, Skin laceration, Syringe issue
Clinical narrative: A chip kicked off and lacerated the index finger; The glass of the bottom part of the syringe cracked/ right above the plunger, at the bottom, near the part of you attach the needle, a chip kicked off; This is a non-serious spontaneous case, initially received from nurse on 20-Nov-2018 and follow up received on 21-Nov-2018 (being processed together), concerning a female patient of an unspecified age.  On 15-Nov-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, batch number: YF42909, expiry date: 30-Jun-2019, dose, route of administration, anatomical location: not reported) for influenza prophylaxis.  It was reported that, during the administration of the vaccine the glass of the bottom part of the syringe cracked and right above the plunger, at the bottom, near the part of needle attachment, a chip kicked off lacerated the index finger of the nurse (explicitly coded as syringe broken).The reporter stated that the crack was in the syringe itself where the needle connected to. It was the lower bottom of the syringe that came off. It was not the luer lock component. It was advised that most likely the other 9 PFS had been used and no issues had been brought to attention at that time. Crack was possibly in between the stopper and luer lock. It was reported that the nurse received first aid treatment after which it got resolved.  On 17-Nov-2018 (reported as about 2 days following the incident), the event laceration was resolved.   This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference numbers were PR11/21/2018 and PR606400.  After completion of a detailed investigation of the affected lot, that included a review of the manufacturing process for lot YF42909, all evidences supported the conclusion that the lot was properly manufactured in accordance with registered conditions and requirements. A review of the complaint questionnaire could not identify a potential cause from the details reported by the complainant, the syringe was provided in a tamper evident blister pack, and no damage to the pack was reported. No other defect was observed prior to the administration of the vaccine. No root cause was identified, and it was concluded that this had been the only reported complaint of this nature for the lot. Furthermore, a review of complaint trends and Adverse Event records illustrated that this was an isolated event, and not symptomatic of a broader issue with lot YF42909 or with the Afluria product range. The root cause of the PTC was assigned as unknown.  Follow up received from nurse on 26-Nov-2018: The reporter stated that the crack was in the syringe itself where the needle connected to. It was the lower bottom of the syringe that came off. It was not the luer lock component. It was advised that most likely the other 9 PFS had been used and no issues had been brought to attention at that time. Crack was possibly in between the stopper and luer lock. The narrative was amended accordingly.  Follow up received from other health professional on 04-Jan-2019: The outcome of the event laceration of finger was updated as recovered in the event tab and it was confirmed that nurse was not exposed to the vaccine. The narrative was amended accordingly.  Follow up received from the QA department on 22-Jan-2019. Based on the QA investigation report, after completion of a detailed investigation of the affected lot, that included a review of the manufacturing process for lot YF42909, all evidences supported the conclusion that the lot was properly manufactured in accordance with registered conditions and requirements. A review of the complaint questionnaire could not identify a potential cause from the details reported by the complainant, the syringe was provided in a tamper evident blister pack, and no damage to the pack was reported. No other defect was observed prior to the administration of the vaccine. No root cause was identified, and it was concluded that this had been the only reported complaint of this nature for the lot. Furthermore, a review of complaint trends and Adverse Event records illustrated that this was an isolated event, and not symptomatic of a broader issue with lot YF42909 or with the Afluria product range. The root cause of the PTC was assigned as unknown. The narrative was amended accordingly.; Reporter's Comments: A female patient of an unspecified age was administered Afluria Quadrivalent, and during the administration the glass of the bottom part of the syringe cracked and right above the plunger, at the bottom, near the part of needle attachment, a chip kicked off lacerated the index finger of the nurse (coded as syringe broken). The company assessed the causality of the event syringe issue as not related to the suspect vaccine considering the event as incidental nature of the event and laceration of finger as not related to the suspect vaccine as it was due to the syringe issue which caused the event.