MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD VIAL ADAPTER; VIAL ADAPTER 13MM FLL SIL VF

Catalog Number	8070117
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
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 a visible small perforation as reported on the tyvek 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
The customer, pfizer contacted the device manufacturer on 30sep2024 to report that during in-process inspection, prior to co-packaging of the vial adapter device with medicinal product, lot j906, the blister of one (1) vial adapter of 315 was found to be perforated at the tyvek.This deficiency was found prior to co-packaging of the device with the drug product and prior use.The device had not yet entered into the distribution stage to the end user (i.E.Being put into service), there was no health impact to the end user.
Additional Manufacturer Narrative
A review of batch records for lot#j906 revealed no non-conformance.All qc inspections were conducted according to procedures, no other issues were identified.According to our records, lot#j906 was manufactured according to relevant procedures, tested before release, packed and shipped according to specifications.Complaints database was reviewed; no justified complaints were identified for this lot.No complaints were received related to lot# j906.Retained samples from lot#j906 were 100% visually inspected by the contract manufacturer - no findings were observed.The returned sample was received on 09-oct-2024 and were inspected, the tyvek was detected with hole.The reported issue was verified.A supplier complaint was sent to the contract manufacturer to investigate this issue.According to the contract manufacturer's preliminary investigation, the batch records were checked, no issues were noticed.This issue was reported with one product out of 180,100 manufactured products therefore considered an isolated event and the root cause of the reported complaint could not be precisely determined.A similar product was tested, and it appears that the defect only occurred after applying local pressure in the spike area.During the entire production process of this item, no point was identified where local pressure could be applied directly above the spike.

• Brand Name: VIAL ADAPTER
• Common Device Name: VIAL ADAPTER 13MM FLL SIL VF
• Manufacturer (Section D): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer (Section G): WEST PHARMA. SERVICES IL, INC.; 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: 20560222
• Report Number: 3000223297-2024-00005
• Device Sequence Number: 8802280
• Product Code: LHI
• UDI-Device Identifier: 07290108240078
• UDI-Public: (01)07290108240078(17)290630(10)J906
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001293
• 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): 01/15/2025

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: 8070117
• Device Lot Number: J906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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