MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD VIAL ADAPTER

Catalog Number	8070101
Medical Device Problem Codes	Contamination (1120); Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigate of this issue is ongoing.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
The customer, dompé farmaceutici, contacted the device manufacturer on 04feb2025 to report that during dispensing of the customer's drug for ophthalmic use, a foreign body was noticed inside a pipette (device which is used for the administration of the drug) after reconstitution with the west vial adapter.No adverse event has been reported as the dose related to the reported event has not been administered.
Additional Manufacturer Narrative
A review of batch records for lot # h190 revealed no non-conformance.All qc inspections were conducted according to procedures, no other issues were identified.According to the manufacturer's records, lot # h190 was manufactured according to relevant procedures, tested before release, packed and shipped according to specifications.Retained samples from lot # h190 were visually inspected by the sub-contractor, no findings were observed.According to available data, the nature and size of the foreign body could not be determined from the photo provided by the manufacturer's customer.Since no sample was received, the complaint subject could not be fully investigated.Therefore, the probable root cause could not be determined.

• Brand Name: VIAL ADAPTER
• Common Device Name: VIAL ADAPTER
• 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: 21518537
• Report Number: 3000223297-2025-00004
• Device Sequence Number: 8335319
• Product Code: LHI
• UDI-Device Identifier: 07290108240498
• UDI-Public: (01)07290108240498(17)260301(10)H190
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072511
• 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): 04/11/2025

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 Expiration Date: 03/01/2026
• Device Catalogue Number: 8070101
• Device Lot Number: H190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2023
• 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