MAUDE Adverse Event Report: ICU MEDICAL, INC. ABG-PROVENT 3ML LI F % 100/CA; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4599P-1
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that they received multiple taps for the syringe cap coming off in route to the lab.It was the purple top tubes.Lab had to be redrawn.There was no reported patient involvement and there was no reported patient injury.
Additional Manufacturer Narrative
H3: one device was received for evaluation.It was reported that the complaint of syringe cap coming of can be confirmed based on the returned images.Without the return of the sample used a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.B3: month and year are known, day is unknown.

• Brand Name: ABG-PROVENT 3ML LI F % 100/CA
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): ICU MEDICAL, INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: reed covert ; 10 bowman drive; keene, NH 03431 ; 2247062300
• MDR Report Key: 24400971
• Report Number: 1217052-2026-00010
• Device Sequence Number: 12801623
• Product Code: JKA
• UDI-Device Identifier: 20351688028638
• UDI-Public: (01)20351688028638
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: Health Professional
• Device Catalogue Number: 4599P-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 02/20/2026
• 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