Sex: U
Vaccine: FLU4
Symptoms: Liquid product physical issue, Product preparation error
Clinical narrative: Found out there are some black particles in one Afluria vial when we tried to draw out the second dose; One dose was administered from the involved vial prior to detection of the black particulate; This spontaneous case initially received on 19-Sep-2023, was reported by a health professional and concerns a(n) patient of unknown age/gender.  Administration of company suspect drug(s): On an unknown date in 2023, the patient was vaccinated with multi-dose vial Afluria Quadrivalent vaccine (Influenza vaccine inact split 4v; dose, route of administration, anatomical location, and indication: not reported). After administration, the pharmacist found out there were some black particles when they tried to draw out the second dose (explicitly coded as 'Particle present in liquid product' and 'Product administration error'). The expiry date reported was P100581940. The batch number reported was P100581940.  No additional suspect drugs.  Adverse reactions/events and outcomes: At the time of follow-up reporting on 22-Mar-2024, it was not reported if the patient experienced any adverse event after vaccination with Afluria Quadrivalent.  Afluria Quadrivalent dechallenge: Not Reported Afluria Quadrivalent rechallenge: Not Reported  Non-drug treatment/Other action taken:  Afluria Quadrivalent action taken: Not Applicable  This case has been entered onto Seqirus' manufacturing quality assurance tracking database (eQMS) and allocated reference number was QE-015567.   Investigation results: In conclusion, the investigation supports that Afluria QIV MDV batch P100581940 was manufactured and released in accordance with registered requirements, there was no manufacturing root cause identified nor was there an indication of a systemic manufacturing defect. No anomalies or issues were identified in the manufacturing process that would have caused this complaint. Additionally, a retain inspection and stability sample review was performed by Seqirus Parkville, in which description testing passed meeting the expected appearance of the Afluria Drug Product for all samples. It was most likely that the foreign particulate was introduced to the vial during the extraction of doses by the complainant. Possibly from a combination of stopper coring from the needle and foreign matter being introduced by the syringe and/or needles supplied by the customer during the extraction process. End user handing was considered the most probable root cause of this event.  Follow-up (22-Mar-2024) from Seqirus' manufacturing quality assurance department: Investigation results were provided. Narrative amended accordingly.; Reporter's Comments: Reportedly, after administration of Afluria Quadrivalent vaccine, the pharmacist found out there were some black particles when they tried to draw out the second dose (explicitly coded as 'Particle present in liquid product' and 'Product administration error'). It was not reported whether the patient experienced any adverse events after vaccine administration. Product administration error and particle present in liquid product are assessed as unrelated per company's conventions.