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

Catalog Number 8072112

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

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

Event Date 12/04/2022

Event Type  malfunction  

Event Description

On 8/31/2022, 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 foreign material adhered to the inside of the sealed packaging of the vial adapter (particulate contamination) prior to use in west tg 8072112 - cn lbl, vendor batch: f047, bayer batch: 271482j.This was found during packaging on six (6) vial adapters out of 24,000 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

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 through an integral plastic cannulated spike located in the center of the vial adapter.Preliminary investigations indicate that lot: f047 was 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.

Manufacturer Narrative

West il investigated on a complaint received by bayer healthcare llc regarding the foreign material adhered to the inside of the sealed packaging of the vial adapter.The products were returned to west il by bayer and inspected by quality assurance (qa).The reported issue was verified.Tested before release, and shipped according to specifications.Batch records review was conducted by qa to detect any issues; no issues were found and no nonconformances were noticed.Qc inspections including visual inspections, in-process, inspection, and final inspection were conducted.No issues were identified for this lot during production/packaging.Raw material for this issue was reviewed from incoming inspection and no issues were identified.Complaints trend for this vial adapter 20mm product family was reviewed for the past 3 years.There were no issues identified.Mdr trending records were reviewed for foreign material for the period of june 2021-november 2022.No issues were found.Ninety (90) retained samples from lot# f047 were inspected for this issue and no issues were identified.The six (6) returned products were found with presence of grease residue.The samples and the grease used in the machines used to manufacture were sent to an external lab to be tested for chemical characterization.The particulates were determined to be a food-grade grease that is supplied by the machine's manufacturer.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: 15465137
• MDR Text Key: 306181211
• Report Number: 3000223297-2022-00003
• 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: 8072112
• Device Lot Number: F047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 12/04/2022
• Supplement Dates FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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