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 hair 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 hair. if additional information is provided, a follow up report will be submitted.  .
Additional Manufacturer Narrative
West pharma services il (west il) investigated on a complaint received by pfizer puurs site supplier regarding a hair found on a vial adapter during incoming inspection.The sample was returned to west il for evaluation on 07-may-2023 and the reported issue was verified.According to the inspection of the received sample, a particle which looked like hair was noticed inside the blister and crossing the sealing area.According to batch records review on lot number f657, this lot was manufactured according to relevant procedures, tested before release, and shipped according to specifications.There were no non-conformances found and no findings were observed.Additionally, no deviations in the production process were found.Retained samples from lot# f657 were visually inspected by the sub-contractor with no findings observed.West il sent a formal request for investigation to the sub-contractor.According to the sub-contractor's report, human hair can enter the product from the clothing of an employee or from the raw material (i.E.Tyvek).Therefore, insufficient procedure for gowning instructions in the clean room, is the most probable root cause for this reported issue.As a result, the sub-contractor updated the procedure for cleaning room gowning and behavior and performed awareness training.The device manufacture date has been corrected to 08may2022 in this report which was previous incorrectly reported as 08may2020.

• Brand Name: VIAL ADAPTER
• Common Device Name: VIAL ADAPTER
• Manufacturer (Section D): WEST PHARMA. SERVICES IL; 4 hasheizaf st; ra'anana, 43664 11; IS 4366411
• 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: 16685426
• Report Number: 3000223297-2023-00002
• Device Sequence Number: 12750149
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: F657
• 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: 08/16/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2022
• 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