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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood exposure occurred during an infusion at the facility, potentially due to either a missing vent filter or a vent filter that became dislodged.The exact cause could not be confirmed.Although the event involved a patient, no patient harm, adverse effects, or injuries were reported.
Additional Manufacturer Narrative
B3 - date of event captured as 01aug2026.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• 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.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50807853
• Report Number: 1219611-2026-00054
• Device Sequence Number: 10549099
• Product Code: JKA
• UDI-Device Identifier: 00351688060214
• UDI-Public: (01)00351688060214
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: G1467J
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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