Sex: F
Vaccine: FLUC4
Symptoms: Exposure via skin contact, Product quality issue, Syringe issue, Underdose
Clinical narrative: This non-serious spontaneous case, was received from other health professional (pharmacist) on 03-Oct-2017, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On 28-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml (as reported), batch number: 195227 and expiry date: May-2018, route of administration: intramuscular and anatomical location: doesn't recall, left or right deltoid (as reported)). On 28-Sep-2017, while administering the vaccine, the needle of the syringe was screwed to give the shot the Luer Lock came apart, the needle and Luer Lock ends up stuck in the patient's arm and it sprayed all over the skin. The patient received partial dose. As per the PTC (product technical complaint) report, no damage was in the package condition or in the syringe (25 gauge, no signs of leakage), but broke when needle was inserted as the hub was loose. It was reported that, the product was stored in the original box until use and placed in a refrigerator. This was a product technical complaint report (reference number: 1025025). It was reported that, the patient had no adverse reaction after receiving the vaccine. From 05-Oct-2017 to 16-Nov-2017, the PTC investigation was carried out for batch no. 195227. As per the investigation performed of the batch production records and manufacturing systems involved in the batch no. 195227, it was found to be unlikely that the defect identified in the complaint was either the result of the manufacturing process or was present in the syringes or stoppers provided by an approved outside vendor. Based on the investigation performed, it could be concluded that FLUCELVAX Batch 195227 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, or relating to the syringes or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for syringes for Luer Lock separation during administration. The most likely root cause can be attributed to improper handling by the user. The reporter assessed the case as non-serious. Follow-up report received on 13-Oct-2017: Route of administration, anatomical location was updated. Event no adverse event was added. Amended narrative accordingly. Non-significant case correction received on 03-Oct-2017: The PTC reference number (1025025) was added. Follow-up received (PTC report) on 16-Nov-2017: As per the investigation performed of the batch production records and manufacturing systems involved in the batch no. 195227, it was found to be unlikely that the defect identified in the complaint was either the result of the manufacturing process or was present in the syringes or stoppers provided by an approved outside vendor. Based on the investigation performed, it could be concluded that FLUCELVAX Batch 195227 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, or relating to the syringes or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017/2018 FLUCLEVAX Commercial Season for syringes for Luer Lock separation during administration. The most likely root cause can be attributed to improper handling by the user. Narrative was amended accordingly. Significant case correction received 13-Oct-2017: The anatomical location was changed from unknown to deltoid in the screen.