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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: neither samples nor pictures were received for the analysis of this complaint.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If device is received at a later date, the file will be reopened and an investigation will be completed.The device history record was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.
Event or Problem Description
It was reported that the patient had a lot of irritation in connection with infusion of chemotherapy on port a cath.The port a cath was discontinued and when the nurse tried to spray water through the catheter a clear leak was seen in the catheter approx.10cm from the port.The port a cath was removed from the patient.Chemotherapy has been given on the port a cath but it has been cleaned and is available for examination.The case has been established as an accidental incident at the hospital.There was patient involvement.
Additional Manufacturer Narrative
Device evaluation: neither samples nor pictures were received for the analysis of this complaint.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If device is received at a later date, the file will be reopened and an investigation will be completed.The device history record was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.
Additional Manufacturer Narrative
H6: evaluation codes update.One device and four photos were received for investigation.The device was visually inspected and functionally tested.The reported complaint was confirmed.A leak was observed during testing.The root cause cannot be determined.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• 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 ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20683024
• Report Number: 9617604-2024-00867
• Device Sequence Number: 17938980
• 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,Followup
• Report Date (Section B): 05/09/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/11/2024; 04/10/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/06/2025; 05/09/2025
• 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