MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC TRAY, POWER PAC II, VEN LP, PU; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4483-24
Medical Device Problem Codes	Break (1069); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
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 female-breast-cancer-patient underwent chemotherapy after surgery, had an infusion port implantation via the jugular vein under ultrasound in march and was readmitted for four chemotherapy cycles.Upon re-admission after completing four cycles of chemotherapy, she was admitted to the hospital for another examination.A chest x-ray showed that the infusion port catheter had broken and fallen into the right atrium.The catheter was then removed via the inferior vena cava.It was mentioned in the complaint that the device is available for return.There was patient involvement, but no patient harm/adverse event reported.
Additional Manufacturer Narrative
No product was returned; however, three photos were received for analysis.The reported issue was confirmed per the photos provided.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: DELTEC TRAY, POWER PAC II, VEN LP, PU
• 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 ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21766116
• Report Number: 1526863-2025-00029
• Device Sequence Number: 8491064
• Product Code: LJT
• UDI-Device Identifier: 10610586032776
• UDI-Public: (01)10610586032776(17)281201(10)4453612
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 21-4483-24
• Device Lot Number: 4453612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female