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

Catalog Number 8072112

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  malfunction  

Event 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.

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.

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.

• Brand Name: VIAL ADAPTER 20MM W/15UM FILTER TG -VF
• Type of Device: 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
• MDR Text Key: 321690541
• Report Number: 3000223297-2023-00013
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 07290108240177
• UDI-Public: 07290108240177
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8072112
• Device Lot Number: H666
• Date Manufacturer Received: 12/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1