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

Model Number 8072043

Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 05/30/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, ferrosan medical devices a/s contacted west il to report that three vial adapter (va) 20mm fll, batch 265307/ lot f420, were scrapped due to incomplete blister pack seals during their kitting process.The reported issue was detected by manual visual control; no machines were involved in the process of handling the vial adapters.The complaint was re-evaluated and deemed as reportable based on a clinical impact assessment dated 12/01/2022.

Manufacturer Narrative

West pharma.Services il ltd.(west) investigated a complaint received regarding 3 vial adapters that were detected during kitting with a fracture over the blister.The returned samples were received on 15june2022 and were inspected.It was determined that two samples were detected with a fracture in the flange area and one sample was detected with a fracture in the plug area -open blister.Sample with a fracture in the plug area could not be simulated.West sent a formal request of investigation to the supplier.West, found that the root cause was a fracture which occurred as a result of an issue with the raw material.Since the products were visually inspected with no evidence of any product with fracture blisters in the plug area, this issue is considered an isolated case.

• 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 PHARMA. SERVICES IL, LTD; 4 hasheizaf street; ra'anana, 43664 1; IS 436641
• Manufacturer Contact: kevin lentz ; 530 herman o. west drive; exton, PA 19341 ; 4844628035
• MDR Report Key: 16052153
• MDR Text Key: 306984116
• Report Number: 3000223297-2022-00006
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8072043
• Device Catalogue Number: 8072043
• Device Lot Number: F420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1