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

Catalog Number	21-4155-24
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
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 information becomes available.The device has not been returned to the manufacturer.
Event or Problem Description
A product liability lawsuit was received through a watch service.The lawsuit alleges the following: on or about (b)(6) 2023, the patient's proport, 21-4155-24, lot number 4307473 was explanted due to infection and chest wall abscess.This device was implanted for the purpose of administering chemotherapy and other treatments associated with testicular seminoma and lymphoma on or about (b)(6) 2023.
Additional Manufacturer Narrative
G1 - mfg contact office city was updated.The suspected device was not received for evaluation.The device history file was reviewed.There were no nonconformities were identified that may have contributed to the reported complaint.The complaint cannot be replicated or confirmed, and a root cause was unable to be determined.A good faith effort was conducted to retrieve the device from the customer.

• Brand Name: DELTEC PROPORT 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: 22498966
• Report Number: 3012307300-2025-08304
• Device Sequence Number: 20576669
• Product Code: LJT
• UDI-Device Identifier: 10610586012594
• UDI-Public: (01)10610586012594(17)270605(10)4307473
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K994216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 21-4155-24
• Device Lot Number: 4307473
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2025
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male