Age: 38.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Device leakage, No adverse event, Product closure issue, Wrong technique in product usage process
Clinical narrative: This is a spontaneous case, initially received from other non-health professional (consumer) on 09-Oct-2018, concerning a 38-year old, adult male patient. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper (explicitly coded as product leakage). One of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole (explicitly coded as product closure issue) where the medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. The doses from the 4 affected MDV that were leaking were administered. On 01-Oct-2018, the patient was administered FLCUELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, deltoid, batch number: 252234, expiry date: 30-Jun-2019] from the leaking vial (explicitly coded as drug administration error). No adverse events were reported after administration of the vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling (explicitly coded as wrong technique in product usage process). The reporter assessed this case as non-serious. This case linked to 201804823, due to the same reporter. Non-significant follow-up received on 09-Oct-2018: It was reported that, while the vaccine was being withdrawn, it leaked from the rubber stopper and when the nurse popped the secured lock off the vial, the rubber stopper was found dented in and off a little. The nurses reported that when they removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication would leak. About five doses could be withdrawn from the vial of 10 doses, the packaging was not damaged and did not appear to be wet. 25gx1 gauge and 3 ml syringe had been used for vaccination. Follow up received from other non-health professional on 26-Oct-2018: The patient's age (38 years) was added in the patient tab. The product start date 01-Ot-2018 was added in the product tab. The event onset date 01-Oct-2018 for the events product leakage and drug administration error was added in the event tab. A new event product closure issue was added in the event tab. The narrative and case comment were amended accordingly. Follow up report received from QA department on 19-Nov-2018: The QA Investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative and the case comment were amended accordingly.