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

Catalog Number	6070030
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 7aug2024, distributor, progressive medical inc., reported that upon opening a box of vial2bag advanced® 20mm admixture devices, 9 units in a box of 50 were observed with damaged primary packaging breaching sterility.The vial2bag devices were not used and there was no harm to reported.
Additional Manufacturer Narrative
This complaint is currently under investigation.The device has not been returned for evaluation, however, a photograph was provided with visible deformities as reported.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Unique device identifier (udi) number corrected.Complaint is currently being investigated by manufacturer.Upon completion of the investigation and if additional information is provided from the manufacturer's customer a follow-up report will be submitted.

• Brand Name: VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE
• Common Device Name: VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE
• Manufacturer (Section D): WEST PHARMACEUTICAL SERVICES AZ, INC.; 7400 e. tierra buena lane; ste. 101; scottsdale AZ 85260
• Manufacturer (Section G): WEST PHARMACEUTICAL SERVICES AZ, INC.; 7400 e. tierra buena lane; ste. 101; scottsdale AZ 85360
• Manufacturer Contact: lynn lundy ; 530 herman o. west drive; exton, PA 19341 ; 4848853298
• MDR Report Key: 20126769
• Report Number: 3015176617-2024-00002
• Device Sequence Number: 20687284
• Product Code: LHI
• UDI-Device Identifier: 10850022888011
• UDI-Public: (01)10850022888011(17)270430(10)K188(90)36098150(91)6070030
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6070030
• Device Lot Number: K188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown