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

Model Number	VIAL2BAG ADVANCED®  20MM ADMIXTURE DEVICE
Medical Device Problem Codes	Contamination (1120); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
West pharma.Services il, ltd.(west israel)  investigated  a complaint received by progressive medical inc.  regarding a vial2bag advanced ® 20mm admixture device where the spike portion was found to be contaminated.  the customer did not return the device to west for evaluation as it was discarded by the facility.  however, a photograph of the device was provided to west and visible contamination of the device was verified.According to the supplier's evaluation, the visible spots on the spike were determined to be embedded spots of degraded plastic material (polyethylene) which occurred during the injection molding process of the cap (shield).  degradation of the plastic occurred due to high temperatures of plasticization group of the molding machine.  additionally, contaminated caps (shields) most likely resulted from insufficient maintenance of the molds and molding machine.  cleaning of the molding machine and presence of the surface sticky mold were implemented by the supplier.
Event or Problem Description
On (b)(6) 2022, progressive medical, inc.Contacted west pharmaceutical services, inc.(west), to report a complaint from a customer that upon opening a vial2bag advanced® 20mm admixture device, lot number f427, the spike portion was found to be contaminated.  it was reported that the device is used for unit mixing of intravenous (iv) piggybacks.Two other packages were opened with the same lot and expiry date and both were visibly clean and appeared uncontaminated.The complaint was re-evaluated and deemed as reportable based on a clinical impact assessment date of (b)(6) 2023.
Additional Manufacturer Narrative
This follow up report is being sent as a correction since the initial mdr submitted on 27feb2023 and filed under manufacturer report number 3000223297-2023-00001, was sent under the incorrect manufacturer report number (3000223297)- west pharma.Services il, ltd.West pharmaceutical services az, inc.(3015176617) is registered as the legal manufacturer and spec developer for the vial2bag advanced® 20mm admixture device.The correct manufacturer report number should be 3015176617-2023-00001.

• Brand Name: VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE
• Common Device Name: VIAL2BAG 20MM
• 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 85260
• Manufacturer Contact: lynn lundy ; 7400 e. tierra buena lane; ste. 101; scottsdale, AZ 85260 ; 4848853298
• MDR Report Key: 16448587
• Report Number: 3000223297-2023-00001
• Device Sequence Number: 5860252
• Product Code: LHI
• UDI-Device Identifier: 10850022888011
• UDI-Public: 10850022888011
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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 Expiration Date: 01/01/2025
• Device Model Number: VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE
• Device Catalogue Number: 6070030
• Device Lot Number: F427
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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