Sex: U
Vaccine: FLU4, FLU4
Symptoms: Accidental underdose, Exposure via skin contact, Syringe issue, Wrong technique in product usage process
Clinical narrative: Leaked out on patient's arm; Medication all leaked out / obtained another prefilled syringe; Medication all leaked; Crack in the hub/luer lok; This case was reported by a nurse via call center representative and described the occurrence of exposure via skin contact in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 3E32Z, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 3E32Z, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season and FluLaval Tetra 2020-2021 season. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season and not applicable after receiving FluLaval Tetra 2020-2021 season, the patient experienced exposure via skin contact, accidental underdose, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the exposure via skin contact, accidental underdose, syringe issue and pharmaceutical product complaint were unknown.  Additional deatils were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Flulaval. While vaccination when needle was inserted into unknown arm of patient, the user pushed on the plunger and all of the medication leaked out of the hub/luer lok and ran down the patient's arm which led to experienced exposure via skin contact, accidental underdose. The user obtained another prefilled syringe of the same lot and noted a crack in the hub/luer lok but still administered the product, indicating that the plunger was compressed slowly which led to syringe issue and pharmaceutical product complaint. One luer lok from lot 3E32Z had a crack in it - unable to obtain details regarding how needles were attached because reporter was not the one that prepared the product for administration. No known damage to the blister/carton.  No damage noted to the syringe barrels. This case was linked with case US2020AMR204491 as reported by same reporter.   Follow up information was received from QA department on 30th November 2020: Summary and conclusions of the QA statement were received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. A customer reported a complaint which falls within the following product technical complaint category: syringe closure defect based on the defect description. An investigation has been conducted, including review of the reported defect trends, the retained samples and our production records, which has demonstrated that the subject batch was produced in compliance with the applicable procedures and met all required specifications. Additionally, no deviation which could be related to the reported complaint has been identified and all of applicable verifications confirmed the conformity of the batch to specifications.   Follow up information was received from QA department on 21st May 2021: Summary and conclusions of the QA statement were received as follows: A customer reported a complaint which falls within the following product technical complaint category:defective syringe cap (crack LLA)based on the defect description. An investigation has been conducted, including review of the reported defect trends, the returned sample, the retained samples and our production records, which has demonstrated that the subject batch was produced in compliance with the applicable procedures and met all required specifications. According to the thorough investigation performed, a root cause was identified at LLA supplier level during its manufacturing process. Therefore, GSK considers this complaint as substantiated.Based on the low occurrence for crack LLA defects (0.11 PPM) and the absence of safety impact for the patient, no corrective action was identified by the supplier. GSK apologizes for any inconvenience caused to the customer.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR204491:same reporter