MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC STANDARD POWER PAC LL IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4476-24
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that several days after the patient's port was explanted, the device was sent to the pathology dept.For testing and was determined to be the source of the patient's persistent infection.Concern was expressed that the materials used in the manufacturing of the catheter contained too high of a concentration of barium sulfate particles for polymer formulation, promoting microfractures and weakening areas that led to the collection and proliferation of blood products, thereby drastically increasing the risk of biofilm, infection, and sepsis.There was patient involvement, and no harm/adverse event reported.
Additional Manufacturer Narrative
H3: reason device not evaluated by mfg: other; device was not returned to manufacturer.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.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: no product was returned.Based on the review of information provided from the customer and no device was returned for review, a product evaluation cannot be performed to confirm the reported problem.If the product is returned at a later date, the complaint will be reopened and an investigation will be completed.The device history record of reported lot number 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.

• Brand Name: DELTEC STANDARD POWER PAC LL IMPLANTABLE PORT
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20878637
• Report Number: 9617604-2024-00925
• Device Sequence Number: 7832043
• Product Code: LJT
• UDI-Device Identifier: 10610586039980
• UDI-Public: (01)10610586039980(17)260329(10)4139529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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 Expiration Date: 03/29/2026
• Device Catalogue Number: 21-4476-24
• Device Lot Number: 4139529
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2021
• 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