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

Model Number 8072050

Device Problems Particulates (1451); Appropriate Term/Code Not Available (3191)

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

Event Date 12/04/2022

Event Type  malfunction  

Manufacturer Narrative

The vial adapter is a single-use device that allows for the transfer of 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.A supplemental report will be filed when more information becomes available.

Event Description

On (b)(6) 2022, baxter healthcare corporation (baxter) contacted (b)(4) to report a foreign material adhered to the inside of the sealed packaging of (b)(4) vial adapter (catalog# 8072050, lot f645).This issue was found by baxter on one vial adapter during their inspection of 10,900 vial adapters.

Manufacturer Narrative

West il investigated a complaint received by baxter healthcare corporation regarding an insect found adhered to the inside of the sealed packaging blister of west's vial adapter (va 20mm ml blue sil - sf) during baxter's inspection of vial adapters.The reported issue was verified.Batch records for catalog# 8072050 with lot# f645 were reviewed.It was found that the product was manufactured according to relevant procedures, tested before release, and shipped according to specifications.Qc inspections including visual, in-process, and final inspections were conducted according to procedures.No issues were identified for this lot during production /packaging.Complaint trends were reviewed for the past three (3) years for this vial adapter 20mm product family.No issues were identified during the review.A review of the mdr trend for the foreign material identified in the complaint was also conducted for the period of june 2021 to november 2022.No significant trend was identified during the review.There were no complaints for the last three (3) years in the complaint database for lot# f645.Ninety (90) retained samples from lot# f645 were inspected for this issue by manufacturing quality and no issues were identified.The sample was returned to west il and inspected by quality assurance (qa).An insect was found inside of the blister pack.The entomological analysis identified the insect as araneae agelenidae.The entomological laboratories could not detect the species of the agelenidae.The root cause was determined to be the sub-contractor's pest control procedure and traps mapping were insufficient as no insect trap was located in the raw materials entrance room.As a result of the findings, the sub-contractor will fumigate around the building every 4 months, add an insect control trap in the rm entrance room, and add controls by additional sampling for biological contamination (insect) for all products manufactured and sampling additional products, according to ansi/asq z1.4 2008 according to aql-0.01 level ii.As a result, the supplier implemented corrective actions; no further actions are currently required from west il.

• 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 19341
• Manufacturer Contact: kevin lentz ; 4 hasheizaf street; ra'anana, 43664-11 ; IS 4366411
• MDR Report Key: 15573258
• MDR Text Key: 306981267
• Report Number: 3000223297-2022-00005
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 07290108241075
• UDI-Public: 07290108241075
• 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

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8072050
• Device Catalogue Number: 8072050
• Device Lot Number: F645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Date Manufacturer Received: 12/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• 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