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

Catalog Number	6070030
Medical Device Problem Codes	Contamination (1120); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
A preliminary investigation was performed by west il.According to west il records, lot# j729 was manufactured according to relevant procedures, and shipped according to specifications.Batch records for lot# j729 were reviewed and there were no non conformances found.Incoming inspection for protector lot j729 was reviewed with no issues observed.90 retained samples from lot# j729 were inspected visually, no issues were observed.No additional complaints were received against lot# j729.According to the supplier of the protector, the embedded spots were determined to be degraded plastic material (polyethylene) which occurred during injection molding process due to high temperatures of plasticization group of the molding machine.The returned samples were received at west il, on (b)(6) 2024 and were inspected.The returned sample was sent to an external lab for analysis and testing.According to the external lab analysis, the material on the protectors (shield) was determined to be wax.A follow up report will be submitted if additional information is received and or upon completion of this investigation.
Additional Manufacturer Narrative
The manufacturer investigated a complaint received by progressive medical, inc regarding one (1) of (b)(4) unopened vial2bag advanced® 20mm admixture devices detected with a foreign dirt-like substance inside and on the primary packaging of the vial2bag device.According to the engineering evaluation, the particles over the protector (shield) were embedded and cannot be removed from protector (shield).Additionally, the assembly process did not contain wax, which was detected according to an external lab analysis.It was determined that the particles are related to the supplier and not related to production process.A supplier investigation was performed.The supplier investigation found that the during the molding process, the machine operated at elevated temperatures.The elevated temperatures were due to a lack of maintenance of the molding machine causing the plastic material to degrade during the injection molding process.This issue resulted in the formation of embedded spots of degraded plastic material in the protectors.The manufacturer will implement corrective actions to improve the detectability including visual sorting of the vial2bag advanced® 20mm admixture devices prior to release for production.Unique device identifier (udi) number corrected.

• 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; 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
• Report Number: 3015176617-2024-00001
• Device Sequence Number: 7102398
• Product Code: LHI
• UDI-Device Identifier: 10850022888011
• UDI-Public: (01)10850022888011(17)261031(10)J729(90)36098150(91)6070030
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2024

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: Other
• Device Catalogue Number: 6070030
• Device Lot Number: J729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 10/09/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 08/02/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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