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

Catalog Number	G1467J
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 3012307300-2025-02031.The date of that submission was 2/19/2025.B3: month and year of event have been provided; day is unknown.Device evaluation: no product has been returned for investigation.A picture was received capturing the issue experienced by the customer.Review of the photo showed that blood had exceeded the acceptance criteria on the filter-pro device, thus complaint confirmation.In-process, filter-pro devices are automatically assembled and glued from supplied components.Without a returned sample to evaluate it could not be stated with confidence whether the area was damaged, had a short fill or was not properly sealed.While the allegation was confirmed, the exact problem source for the compromised filter-pro could not be identified with any confidence.No further action will be conducted at this time.A device history record (dhr) review reported no discrepancies or non-conformance's during the manufacturing of the reported lot number.
Event or Problem Description
It was reported that blood leaked from the filter pro and from the gaps in the syringe when blood was drawn.There were no patient harm or adverse event reported as a result of the event.

• 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 ; 10 bowman dr; keene, NH 03431 ; 2247062300
• MDR Report Key: 24673742
• Report Number: 1217052-2026-00013
• Device Sequence Number: 10215004
• Product Code: JKA
• UDI-Device Identifier: 00351688060214
• UDI-Public: (01)00351688060214(17)270520(10)6020314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: Health Professional
• Device Catalogue Number: G1467J
• Device Lot Number: 6020314
• 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: 01/28/2025
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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