MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD VIAL ADAPTER 20MM W/15UM FILTER TG -VF

Catalog Number	8072112
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	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, bayer, contacted west pharmaceutical services, inc.(west), to report that during incoming inspection of the west il, vial adapter, lot h666, 1 of 500 products has a visible incomplete blister seal.
Additional Manufacturer Narrative
West il is currently investigating this complaint.The device has not been returned to west il for an evaluation.However, a photograph was provided to west il which showed the incomplete blister seal.Upon completion of the west il investigation and if additional information is provided from the customer, a follow up report will be submitted.
Additional Manufacturer Narrative
A preliminary investigation was performed by west il.According to west il records, lot# h666 was manufactured according to procedures, tested before release, shipped according to specifications and sealed by an automatic ffs sealing machine.Batch records for lot# h666 were reviewed and no ncm's were found.All qc inspections were conducted according to the procedures, no issues were noticed.Retained samples from lot# h666 were 100% inspected by the subcontractor, no issues were observed.Ninety retained samples of lot# h666 were visually inspected by west il, all samples were found intact.The returned samples were received at west il and inspected.From the returned samples, a vial adapter was observed to be in a half-opened blister, the blister was flattened, deformed.An official supplier complaint was sent to the contract manufacturer with a request for investigation.According to the contract manufacturer investigation, the batch records for the manufacturing of this lot were reviewed and no issues were found.Maintenance logbook was check and all was found intact for this period.In process testing for damages in tyvek/blister was performed for 3,971 products, and final testing was performed for 7,500 products, no issues were reported.Deviations from product's height were monitored, no issues were reported.A sampling of 5,020 products was conducted for the sealing criteria, no issues were reported.The batch records for consecutive lots manufactured before and after lot# h666 were reviewed, no findings were found regarding this reported issue.The return process has been initiated and is currently ongoing.A follow up report will be submitted if additional information is received and or upon completion of this investigation.
Additional Manufacturer Narrative
According to our internal investigation of lot# h666 was manufactured according to the relevant procedure, tested before release, packed and shipped according to the device specifications.Complaints database of the last three years was reviewed, no justified complaints were found for this product cat# 8072112.Retained samples from lot#h666 were 100% visually inspected by the cm during production, per procedure - no findings were observed.According to the shipping vendor's investigation, the shipment was sent under temperature control 15-25 along all the supply chain.Due to the time that has passed, it is not possible to obtain printouts of the recorded temperature set in the trucks or warehouses.It is not possible to determine if the heat exposure occurred prior to the arrival of the goods in ben gurion airport or after the delivery of the goods at the consignee warehouse.The root cause of this event is due to insufficient temperature monitoring over the entire door to door shipment process.

• Brand Name: VIAL ADAPTER 20MM W/15UM FILTER TG -VF
• Common Device Name: VIAL ADAPTER 20MM W/15UM FILTER TG -VF
• Manufacturer (Section D): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf st; ra'anana, 43664 11; IS 4366411
• Manufacturer (Section G): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf st.; ra'anana 43664 11; IS 4366411
• Manufacturer Contact: lynn lundy ; 530 herman o. west dr; exton, PA 19341 ; 4848853298
• MDR Report Key: 17597321
• Report Number: 3000223297-2023-00013
• Device Sequence Number: 7420391
• Product Code: LHI
• UDI-Device Identifier: 07290108240177
• UDI-Public: 07290108240177
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 8072112
• Device Lot Number: H666
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 12/17/2023; 12/26/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 01/11/2024; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2023
• 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