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

Model Number VIAL2BAG ADVANCED®  20MM ADMIXTURE DEVICE

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

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

Event Date 06/26/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 310690809
• Report Number: 3000223297-2023-00001
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE
• Device Catalogue Number: 6070030
• Device Lot Number: F427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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