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

Catalog Number	8072109
Medical Device Problem Codes	Material Disintegration (1177); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer, bayer u.S.Llc pharmaceuticals, contacted the device manufacturer on 28 feb 2025 to report that a foreign particle was discovered in a reconstituted vial of the customer's drug product.The reported particle was identified by the customer as polyethylene terephthalate (pet), a member of the polyester family.
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.
Additional Manufacturer Narrative
Additional information received by the manufacturer's customer noting vial adapters are utilized to reconstitute the customer's drug product for quality control testing.After reconstitution of the customer's drug product, a particle was observed in a vial.According to the manufacturer's records, lot j836 was manufactured in accordance with relevant procedures, tested before release and shipped according to specifications.Batch records for lot j836 were reviewed; no non-conformances were found.All qc inspections were conducted according to procedures during production; no deviations were noticed.The final lot sent to the manufacturer's customer meets quality, safety and functionality requirements.Complaints database of the last three years was reviewed: no justified complaints were found for the lot j836; no justified complaints were found for the same catalog; no justified complaints were found for the reported issue.Retained samples from lot j836 were 200% visually inspected by the contract manufacturer; no deviations were observed.According to the manufacturer's customer, the particle that was found was tested and was identified as pet polyethylene terephthalate.According to the report analysis; the material, dimensions, and configuration of the particle examined is closely consistent with that of the filter mesh fibers used in the manufacturer's vial adapter device.As part of the investigation, the manufacturer performed functionality and analytical testing on returned samples from lot j836 from the manufacturer's customer as well as the manufacturer's retained samples from lot j836.All products met the testing requirements.The manufacturer was unable to identify or simulate the reported particle since the particle was found in the vial after reconstitution and before the drug was withdrawn into the syringe.The particle had not yet been filtered by the manufacturer's product and would not pass into the syringe.Therefore, the root cause for the particle on the customer site could not be determined and no corrective action could be identified by the manufacturer.

• 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: 21698154
• Report Number: 3000223297-2025-00005
• Device Sequence Number: 15807403
• Product Code: LHI
• UDI-Device Identifier: 07290108240191
• UDI-Public: (01)07290108240191(17)281230(10)J836
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K963583
• 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): 08/20/2025

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: 8072109
• Device Lot Number: J836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2024
• 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