MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC POWER PORT-A-CATH II PORTS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4455-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/19/2024
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 during treatment of a cancer patient, resistance at the inlet into the device was found.This reportedly led to the patient feeling pain.The device was transilluminated with contrast and a leak was found in the hose.Due to this, the device was surgically removed and replaced with a new one to continue treatment.After the revision of the device, no patient harm was reported.
Additional Manufacturer Narrative
H3: the device was received for evaluation as well as four photos.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Visual and functional tests were performed, which found a leak confirming the defect in the catheter.According to the ifu, the catheter needs to be purged before to start using.According to the report the catheter was already implanted to the patient when the problem was identified.The root cause cannot be determinate to the manufacturing process.

• Brand Name: DELTEC POWER PORT-A-CATH II PORTS
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21061044
• Report Number: 9617604-2025-00005
• Device Sequence Number: 8153673
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: (01)10610586032707(17)281006(10)4449235
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K072657
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 21-4455-24
• Device Lot Number: 4449235
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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