MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD VIAL ADAPTER; VIAL ADAPTER 20MM FLL SIL W/5 UM FILTER - VF

Catalog Number	8072107
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is currently being investigated by manufacturer.The device has not been returned for an evaluation.However, a photograph was provided with visible primary packaging compromise of the device.Upon completion of the investigation and if additional information is provided from the manufacturer's customer a follow-up report will be submitted.
Event or Problem Description
On 23oct2024, the customer, sanofi pharmaceutical contacted the manufacturer, to report that when the end user opened the kit of the co-packaged vial adapter, kitted with a sanofi medicinal product, the primary packaging of the vial adapter 20mm w/5mic filter, lot# h275, was compromised breaching sterility.The end user administered the dose using another vial adapter.There was no health impact to the end user as this issue was detected prior to use.
Additional Manufacturer Narrative
A review of batch records for lot#h275 revealed no non-conformance.All qc inspections were conducted according to procedures, no other issues were identified.According to the manufacturer's records, lot#h275 was manufactured according to relevant procedures, tested before release, packed and shipped according to specifications.Complaints database of the last three years was reviewed; two complaints were justified for this lot.Retained samples from lot#h275 were visually inspected, no findings were observed.According to the sub-contractors' review for seal integrity testing records, no issues were noticed.However,instructions for the manufacturing line were written as immediate correction to avoid this issue from recurring.The sample was returned to the manufacturer and the issue was verified.The root cause of the unsealed products is due to insufficient execution of procedure.The products were manually removed instead of being scrapped or continued through an additional sealing round.

• Brand Name: VIAL ADAPTER
• Common Device Name: VIAL ADAPTER 20MM FLL SIL W/5 UM FILTER - VF
• Manufacturer (Section D): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer (Section G): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer Contact: lynn lundy ; 530 herman o. west drive; exton, PA 19341 ; 4848853298
• MDR Report Key: 20734933
• Report Number: 3000223297-2024-00008
• Device Sequence Number: 8648958
• Product Code: LHI
• UDI-Device Identifier: 07290108240184
• UDI-Public: (01)07290108240184(17)280101(10)H275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 8072107
• Device Lot Number: H275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown