Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Product leakage, Wrong technique in product usage process
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 02-Oct-2018, concerns a 50-year-old, adult, female patient. On 27-Sep-2018, the patient was administered FLUCELVAX QIVc [batch number: 252235 and expiry date: 30-Jun-2019, dose: 0.5 ml (reported as full dose), route of administration: intramuscular and anatomical location: deltoid] from a leaking vial for active immunization against influenza. It was reported that, the vial was held upside down and every time when a dose was pulled from the vial, it was leaking. Two doses were already lost. The defect was discovered during drawing up of the vaccine. The package and the vials were not damaged or wet. The leakage was observed after withdrawal of first dose out of 7-8 doses. The needle of size 22 gauge was used to draw vaccine from 5 ml syringe. At the time of this report, no adverse event was reported after administration of the vaccine. This case is linked to the original case 201804221 (same reporter). This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1033781. Based on the QA investigation, it was concluded that, the Batch Production Records and Manufacturing Systems involved in Batch 252235, found it to be unlikely that the Leaking Vial defect identified in this complaint was the result of the manufacturing process at the facility. The complainant stated that the vial was inverted when removing the needle from the vial. The complainant stated that air was introduced into the vial prior to extracting the doses. Both the Centers for Disease Control (CDC) and Library of Medicine indicated that injecting air was not recommended because it would cause leaking or spritzing of the vaccine from the vial. It had been established that the addition of air to the vial could over pressurize the vial and cause leaking and this practice was not recommended. The root cause for the leaking FLUCELVAX MDV of Batch 252235 was due to user or improper handling. The reporter assessed the case as non-serious. Follow-up received from Quality assurance (QA) team on 02-Oct-2018: The product quality complaint (PTC) reference number 1033781 was added in additional information tab. The dose (0.5ml) was added. It was reported that, the vial was held upside down and every time when a dose was pulled from the vial, it was leaking. Two doses were already lost. The defect was discovered during drawing up of the vaccine. The package and the vials were not damaged or wet. The leakage was observed after withdrawal of first dose out of 7-8 doses. The needle of size 22 gauge was used to draw vaccine from 5 ml syringe. The narrative was amended accordingly. Follow-up received on quality assurance department 02-Oct-2018: The onset date (27-Sep-2018) for the event product leakage was added in the event tab. Added dose (0.5 ml) in the product tab. The product quality complaint (PTC) reference number 1033781 was added in additional information tab. It was reported that, the vial was held upside down and every time when a dose was pulled from the vial, it was leaking. Two doses were already lost. The defect was discovered during drawing up of the vaccine. The package and the vials were not damaged or wet. The leakage was observed after withdrawal of first dose out of 7-8 doses. The needle of size 22 gauge was used to draw vaccine from 5 ml syringe. The narrative was amended accordingly. Significant follow up received from the reporter on received on 16-Oct-2018: The reporter confirmed the dose as 0.5 ml, the route of administration (intramuscular) and anatomical location (deltoid) was updated in the product tab and the narrative was amended accordingly. Non-significant follow up received from other health professional on 26-Oct-2018: No additional information was received hence no changes were made in the narrative. Follow up report received from QA department on 13-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252235 was due to user or improper handling. Added new event in event tab. The narrative was amended accordingly. Reporter's Comments: A 50-year-old female patient was administered FLUCELVAX QIVc from a leaking vial due to user or improper handling. The company assessed the event product leakage as not related due to incidental nature of the event and events drug administration error and wrong technique in product usage process as not related due to accidental nature of the events.