MAUDE Adverse Event Report: ICU MEDICAL ASD, INC. PORTEX ABS LINEDRAW DRY HEPARIN; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4043E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that when drawing an arterial blood gas, blood leaked out of the syringe beneath the plunger and was broken.There was patient involvement, but no injury.
Additional Manufacturer Narrative
One used sample was received for evaluation for the complaint that when drawing an arterial blood gas, blood leaked out of the syringe beneath the plunger and was broken.As received no damage or anomalies were observed.The lot history review could not be completed because no verifiable lot number was available in the system records due to keene transition.In attempts to replicate clinical use red dye was pulled into the syringe.A leak was observed to be coming from the plunger area.The fluid was pushed out and the plunger was pulled out.A piece of the black rubber was observed to be carved out.The complaint of leakage can be confirmed due to the damage found on the plunger.The probable cause of the damage is unknown.
Additional Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed during functional testing when the reported issue was duplicated.The issue was traced to the syringe plunger, which was determined to be damaged.However, no root cause could be determined for the observed damage.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: PORTEX ABS LINEDRAW DRY HEPARIN
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): ICU MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23828876
• Report Number: 3012307300-2025-13579
• Device Sequence Number: 9288603
• Product Code: JKA
• UDI-Device Identifier: 20351688039184
• UDI-Public: (01)20351688039184(17)280707(10)6131816
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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: 4043E
• Device Lot Number: 6131816
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/23/2026; 03/26/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/02/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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