MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC PROPORT PLASTIC TRAY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4153-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
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 after the catheter's reservoir was installed, it leaked and completely fell apart under the subcutaneous tissue.It was necessary to completely remove it and reinstalled a new one.There were patient harm or adverse events reported as a result of the event.
Additional Manufacturer Narrative
D9: date returned to mfg; 12/23/2024.Device evaluation: one device and three photos were received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Visual inspection and functional testing performed during analysis.The images showed the housing was separated from the port upon removal from the patient.The customer reported complaint was confirmed due to the observation of the separation on the port.The probable cause is a welding error.

• Brand Name: DELTEC PROPORT PLASTIC TRAY
• 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
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21337650
• Report Number: 9617604-2025-00114
• Device Sequence Number: 11701994
• Product Code: LJT
• UDI-Device Identifier: 10610586012563
• UDI-Public: (01)10610586012563(17)290106(10)6001912
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K994216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 21-4153-24
• Device Lot Number: 6001912
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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 Age: 42 YR
• Patient Sex: Female