MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD VIAL ADAPTER 13MM LONG W/25MIC FILTER VF

Catalog Number	8070201
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
West pharma.Services il, ltd.(west il) is currently investigating this complaint.Per the customer, the device will not be 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 (b)(6) 2024, the customer, novo nordisk, contacted west pharma.Services, il ltd.(west il), to report that during the in process inspection, prior to release to the market of the vial adapters, a loose black particulate matter was observed within the vial adapter blister pack.The affected lot number involved in this reported event is f768.
Additional Manufacturer Narrative
West pharma services il (west il) investigated on a complaint received by novo nordisk regarding a loose black particulate matter observed within the vial adapter blister pack.According to batch records review, lot number f768 was manufactured according to relevant procedures tested before release and shipped according to specifications.There were no non-conformances found.No other complaints were received from lot# f768.The incoming inspection of the blister used for lot#f768 were reviewed, no issues were found.90 units from retained samples of lot# f768 were visually inspected, no issues were noticed.The sample was not returned to west il for evaluation.However, a photo of the sample was provided.According to the photo, it could not be determined if the particle was located inside the blister or outside of the blister.According to available information, the root cause could not be determined.

• Brand Name: VIAL ADAPTER 13MM LONG W/25MIC FILTER VF
• 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 dr; exton, PA 19341 ; 4848853298
• MDR Report Key: 19238381
• Report Number: 3000223297-2024-00001
• Device Sequence Number: 8049095
• Product Code: LHI
• UDI-Device Identifier: 07290108240245
• UDI-Public: 07290108240245
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 08/09/2024

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: 8070201
• Device Lot Number: F768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 07/21/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2023
• 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