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	08/07/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 08aug2024, west pharma services distributor, (b)(4)., contacted west pharma.Services, il ltd.(b)(6), to report that upon opening a box of vial2bag advanced¿ 20mm devices, several packages were not properly sealed and appear to have gaps in the glue.The customer inspected 2 boxes and has 3 unopened boxes of lot k194 that they do not want to use.The customer also noted that they have 61 individual packages of the same lot.However, not all of these 61 individual packages are opened by the customer.The vial2bag devices were not used and there was no harm to reported.
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.; 400 e. tierra buena lane; ste. 101; scottsdale AZ 85260
• Manufacturer (Section G): WEST PHARMACEUTICAL SERVICES AZ, INC.; 400 e. tierra buena lane; ste. 101; scottsdale AZ 85260
• Manufacturer Contact: lynn lundy ; 530 herman o. west dr; exton, PA 19481 ; 4848853298
• MDR Report Key: 20126114
• Report Number: 3015176617-2024-00003
• Device Sequence Number: 18013137
• Product Code: LHI
• UDI-Device Identifier: 10850022888011
• UDI-Public: (01)10850022888011(17)270430(10)K194(90)36098150(91)6070030
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: K194
• 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: 08/08/2024
• 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: 05/26/2024
• 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