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

Catalog Number 8072108

Device Problems Particulates (1451); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

The vial adapter is a single-use device that allows for transferring fluids out of and into drug vials.The device is a one-piece polycarbonate molded part with a standard female or male luer port for connecting a syringe.Puncturing the elastomeric closure of a drug vial is achieved manufactured according to relevant procedures and tested before release and shipment.Batch records, logbooks, and retained sample evaluation identified no issues.(b)(4) units were tested during in-process testing for foreign matter and no issues were detected.Once samples arrive, they will be tested for chemical characterization.A supplemental report will be filed when more information becomes available.

Event Description

On (b)(6) 2022, bayer healthcare llc contacted west pharma.Services il, ltd.(west) to report a repeat instance of foreign material adhered to the inside of the sealed packaging of the vial adapter (particulate contamination) prior to use in west tg 8072108 ce mrk, vendor batch e188, bayer batch 2712w08.This was found during packaging on three (3) vial adapters out of 500 inspected.Photographs from the customer are available upon request.The customer has sent the samples to west but at the time of this report, they have not been received.

Manufacturer Narrative

West il investigated on a complaint received by bayer healthcare llc regarding three (3) vial adapters that showed foreign material.The samples were returned to west il by bayer and inspected by quality assurance (qa).The reported issue was verified.Production records were reviewed for lot# e188; the records showed that the lot was manufactured according to relevant procedures, tested before release, and shipped according to specifications.Batch records were reviewed to detect any issues; no issues were found and no nonconformances were identified.Qc inspections including visual inspections, in-process inspection, and final inspection were reviewed.No issues were identified for this lot during production/packaging.Incoming inspection for the raw materials were reviewed by a qa and no issues were observed.Complaint trending information for the past three (3) years was reviewed for this vial adapter 20mm product family.No issues were found.Mdr trending information for the reported issue of foreign material was reviewed for the timeframe june 2021 to november 2022.No issues were found.Ninety (90) retained samples from lot #e188 were inspected for this issue and no issues were identified.The three (3) returned samples and the grease used in the machines were sent to an external lab and tested for chemical characterization.The particulates were determined to be a food-grade grease that is supplied by the machine's manufacture.The inspected material was determined as non- biological.The most probable root cause of the reported event is that the grease residues originated from the seal machine grease.The grease residues first encountered the blister during the sealing process on the seal machine, right after the forming stage.West il notified the sub-contractor and instructed them to stop production on all machines used to manufacture the product due to the reported event.The subcontractor cleaned the gears.Following the cleaning preformed on two productions, lots were 100% visually inspected for particles.No findings were observed.Based on the results, it was concluded that the cleaning actions were effective.

• Brand Name: VIAL ADAPTER
• Type of Device: VIAL ADAPTER
• Manufacturer (Section D): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer (Section G): WEST PHARMACEUTICAL SERVICES, INC.; 530 herman o. west drive; exton PA 19341
• Manufacturer Contact: kevin lentz ; 4 hasheizaf street; ra'anana, 43664-11 ; IS 4366411
• MDR Report Key: 15465094
• MDR Text Key: 306180018
• Report Number: 3000223297-2022-00002
• Device Sequence Number: 1
• Product Code: LHI
• 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: 12/27/2022

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
• Device Operator: Other
• Device Catalogue Number: 8072108
• Device Lot Number: E188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• 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