MAUDE Adverse Event Report: ICU MEDICAL, INC. DELTEC PROPORT PORTS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4591-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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 information becomes available.
Event or Problem Description
It was reported that the tube exhibited a leakage during use.There was patient involvement, no injury was reported.
Additional Manufacturer Narrative
One sample was returned for evaluation.Review of the lot history revealed no nonconformities that could have contributed to the reported complaint.The device was visually inspected, with no physical damage or anomalies observed.The catheter was connected to the port according to the ifu, fully seated on the connector bulb, and secured with the ultra-lock.A syringe and needle were then attached to the port, and 10 ml of water was primed.No leakage was observed, and free flow through the catheter was confirmed.The complaint could not be reproduced, and no root cause could be identified.

• Brand Name: DELTEC PROPORT PORTS
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24791049
• Report Number: 3012307300-2026-03319
• Device Sequence Number: 18304323
• Product Code: LJT
• UDI-Device Identifier: 10610586021565
• UDI-Public: (01)10610586021565(17)290601(10)6077436
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961580
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: Lay User/Patient
• Device Catalogue Number: 21-4591-24
• Device Lot Number: 6077436
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2024
• 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