MAUDE Adverse Event Report: West Pharma. Services IL, Ltd. Swabable Vial Adapter 13mm; Set, I.V. Fluid Transfer

Catalog Number	8070101
Medical Device Problem Codes	Contamination (1120); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction

• Brand Name: Swabable Vial Adapter 13mm
• Common Device Name: Set, I.V. Fluid Transfer
• Manufacturer (Section D): West Pharma. Services IL, Ltd.; 4 hasheizaf street; ra'anana; 43664 1; IS 436641
• 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: 50069903
• Report Number: 3000223297-2026-00027
• Device Sequence Number: 10206663
• Product Code: LHI
• UDI-Device Identifier: 07290108240498
• UDI-Public: (01)07290108240498(17)290130(10)L896
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072511
• 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,Followup
• Report Date (Section B): 09/24/2026

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: 8070101
• Device Lot Number: L896
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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