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

Model Number	8070117
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted west il to report that during visual incoming inspection of vial adapter; the visual inspection found contamination of a fiber which was in direct contact with the vial adapter.  this was found prior to patient use.    the customer did not return the device to west for evaluation.  however, a photograph of the device was provided to west and visible contamination of the device was verified as contamination of fiber.  if additional information is provided, a follow up report will be submitted.  .
Additional Manufacturer Narrative
Investigation completed on 24apr2023. a batch review was performed internally by west il on retained samples of the affected lot f655.  this is the same lot that was reported in the initial report.  upon internal review,  there were no non-conformances found and no findings were observed.  additionally, no deviations in the west il production process were found.  as the affected device reported by the customer was not returned for an evaluation, the root cause of the reported issue could not be determined.  there is no indication how the reported fiber came in contact with the vial adapter.  therefore, no corrective action can be identified by west il.  according to the available information, the root cause for the reported complaint could not be accurately determined.
Additional Manufacturer Narrative
The returned sample involved in this event was received at west il for evaluation.Upon inspection, a white fiber was observed wrapped around the spike of the vial adapter.There is no indication how the reported issue may have occurred, as the vial adapter was taken out of the blister.Since the primary package was already open, the most probable root cause could not be determined as it was not possible to track where or how the fiber had entered the vial adapter.No corrective action can be identified by west il.

• Brand Name: VIAL ADAPTER
• Common Device Name: VIAL ADAPTER
• Manufacturer (Section D): WEST PHARMA. SERVICES, IL; 4 hasheizaf st; ra'anana 43664
• Manufacturer (Section G): WEST PHARMA. SERVICES, IL; 4 hasheizaf st; ra'anana, 43664 11; IS 4366411
• Manufacturer Contact: lynn lundy ; 530 herman o. west drive; exton, PA 19341 ; 4848853298
• MDR Report Key: 16685525
• Report Number: 3000223297-2023-00003
• Device Sequence Number: 7989313
• Product Code: LHI
• UDI-Device Identifier: 07290108240078
• UDI-Public: 07290108240078
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2024

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 Model Number: 8070117
• Device Catalogue Number: 8070117
• Device Lot Number: F655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 01/04/2024
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/23/2023; 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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