MAUDE Adverse Event Report: WEST PHARMA SERVICES IL, LTD VIAL ADAPTER; VIAL ADAPTER 20MM FLL W/ RIBS

Catalog Number	8072045
Medical Device Problem Codes	Contamination (1120); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
West pharma.Services il, ltd.(west il) is currently investigating this complaint.The device has not yet been returned to west il for an evaluation.However, a photograph was provided to west il with visible particles as reported inside of the packaged device.Upon completion of the west il investigation and if additional information is provided from the customer a follow up report will be submitted.
Event or Problem Description
On 13may2024, the customer, ferring pharmaceuticals, contacted west pharma.Services, il ltd.(west il), to report that during assembly of ferring's combination pack, a vial adapter, was observed with a blue foreign particulate matter within the primary sterile package.Subsequently, the customer observed a second vial adapter with another blue foreign particulate matter within the primary sterile package.Both vial adapters are from lot # f700.The west pharma.Vial adapters are co-packed with the drug firmagon, this medication is to be administered subcutaneously as an injection.Batch records for lot# f700 were reviewed and there were no non conformances found.Quality control inspections were conducted according to procedures during production, no issues were noticed.The incoming inspection records of the tyvek and needles were reviewed, no issues were noticed.Lot #f700 was manufactured according to relevant procedures tested before release and shipped according to specifications.Retained samples from lot #f700 were 100% visually inspected by the contract manufacturer according to their internal procedure, no findings were observed.
Additional Manufacturer Narrative
Unique device identifier (udi) # corrected.Complaint is currently being investigated by manufacturer.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
The returned samples were received at the manufacturer and were inspected.According to the inspection of the received samples, free blue foreign material was found inside both sealed products.The reported issue of particles inside the product was verified.An official supplier complaint was sent to the contract manufacturer with the samples and request for investigation.According to the contract manufacturer's report, the batch records for lot# f700 were reviewed, no issues were reported.In-process and final inspection of products was performed; no issues were found.Therefore, the root cause was determined to be due to environmental factors during the manufacturing process.The particles can be from raw materials, operators, or air ventilation when manufactured.No corrective action from the manufacturer is required.However, as a corrective action, the contract manufacturer implemented training for all relevant employees regarding this complaint.

• Brand Name: VIAL ADAPTER
• Common Device Name: VIAL ADAPTER 20MM FLL W/ RIBS
• 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: 19520328
• Report Number: 3000223297-2024-00002
• Device Sequence Number: 6030800
• Product Code: LHI
• UDI-Device Identifier: 07290108240412
• UDI-Public: (01)07290108240412(17)270401(10)F700
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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: 8072045
• Device Lot Number: F700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: Not provided; 07/02/2025
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 10/17/2024; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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