MAUDE Adverse Event Report: ICU MEDICAL, INC. DELTEC TITANIUM PORT-A-CATH, LOW PROFILE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4009-24
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.Lot number 21095215 was reported by the customer; however it was not found as in the system.
Event or Problem Description
It was reported that there was difficulty in dripping from the catheter and pain after puncture.An x-ray was performed, and it was found that the catheter was ruptured.The event took place during a treatment in the oncology department.The event occurred during patient use; however, no harm was reported.

• Brand Name: DELTEC TITANIUM PORT-A-CATH, LOW PROFILE
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; industrial internacional; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22804284
• Report Number: 3012307300-2025-09684
• Device Sequence Number: 9063775
• Product Code: LJT
• UDI-Device Identifier: 10610586023750
• UDI-Public: (01)10610586023750
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830730
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: 21-4009-24
• Device Lot Number: 21095215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/14/2025
• 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