MAUDE Adverse Event Report: WEST PHARMACEUTICAL SERVICES AZ, INC. VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE

Catalog Number 6070030

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

On 20mar2024, (b)(6).Contacted west pharmaceutical services, inc.(west), to report that on 19mar2024, a materials manager at a hospital noticed that one of the unopened vial2bag advanced® 20mm admixture device blister pack appeared to have a foreign dirt-like substance inside of it and on the vial2bag device.The product was not opened, nor was it used.There was no harm to any patient or staff.

Manufacturer Narrative

West pharma.Services, ltd.Is currently investigating this complaint.The device has not yet been returned to west for an evaluation.However, a photograph was provided to west with visible particles as reported inside of the packaged device.Upon completion of the west investigation and if additional information is provided from the customer a follow up report will be submitted.

• Brand Name: VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE
• Type of Device: VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE
• Manufacturer (Section D): WEST PHARMACEUTICAL SERVICES AZ, INC.; 7400 e. tierra buena lane; suite 101; scottsdale AZ 85260
• Manufacturer (Section G): WEST PHARMACEUTICAL SERVICES AZ, INC.; 7400 e. tierra buena lane; suite 101; scottsdale AZ 85260
• Manufacturer Contact: lynn lundy ; 530 herman o. west drive; exton, PA 19341 ; 4848853298
• MDR Report Key: 19115714
• MDR Text Key: 341263614
• Report Number: 3015176617-2024-00001
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10850022888011
• UDI-Public: 10850022888011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2024

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: 6070030
• Device Lot Number: J729
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2023
• 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