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

Catalog Number	21-4591-24
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device not received by manufacturer.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 the placement of the implantable drug delivery device, the metal stem and catheter of the connection part of the port seat were found to be detached when the catheter was connected to the port seat after the catheter was inserted, so the product was replaced.There was patient involvement reported and no patient harm/adverse event reported.
Additional Manufacturer Narrative
No product sample was received.One photo was provided by the customer, and the reported failure was confirmed.In case the sample was returned, this complaint will be re-opened to perform the corresponding evaluation.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
One device and one photograph was received for investigation.The reported issue was confirmed during visual inspection of the sample device and the photograph, which verified the metal catheter port was separated from the white port body.Further investigation of the sample confirmed that the device dimensions were within specification.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.However, the investigation attributed the observed condition to an error in the welding process during manufacturing.

• Brand Name: DELTEC P.A.S.PORT 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: 21129561
• Report Number: 9617604-2025-00035
• Device Sequence Number: 20728658
• Product Code: LJT
• UDI-Device Identifier: 10610586021565
• UDI-Public: (01)10610586021565(17)280105(10)6023289
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2025

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: Other
• Device Catalogue Number: 21-4591-24
• Device Lot Number: 6023289
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 09/26/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/10/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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