MAUDE Adverse Event Report: West Pharma. Services IL, Ltd. Mix2Vial 20/20; Set, I.V. Fluid Transfer

Catalog Number	900165
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction

• Brand Name: Mix2Vial 20/20
• Common Device Name: Set, I.V. Fluid Transfer
• Manufacturer (Section D): West Pharma. Services IL, Ltd.; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer (Section G): West Pharma. Services IL, Ltd.; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer Contact: lynn lundy ; 530 herman o. west drive; exton, PA 19341 ; +1(484)885-3298
• MDR Report Key: 50157968
• Report Number: 3000223297-2026-00042
• Device Sequence Number: 9341304
• Product Code: LHI
• UDI-Device Identifier: 07290108240801
• UDI-Public: (01)07290108240801(17)310331(10)L638
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 900165
• Device Lot Number: L638
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/06/2026
• 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