MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX ABS PRO-VENT ARTERIAL BLOOD SAMPLING; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4598P-2
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).H3: neither product samples, pictures, or videos were received for investigation.The complaint of needle falling off could not be confirmed by investigation.Without the return of the product a comprehensive failure investigation could not be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record could not be completed as no complaints documented for this lot number.
Event or Problem Description
It was reported that while attempting to deploy needle safety system, a needle fell off and poked the rt.There was unknown patient involvement.

• Brand Name: PORTEX ABS PRO-VENT ARTERIAL BLOOD SAMPLING
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): ICU MEDICAL, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23658146
• Report Number: 3012307300-2025-12937
• Device Sequence Number: 13252297
• Product Code: JKA
• UDI-Device Identifier: 20351688040333
• UDI-Public: (01)20351688040333
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: 4598P-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 11/26/2025
• 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