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	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither samples nor pictures were received for analysis.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the used samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.The service history review had no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was reported that the port leaked causing shoulder pain.There was patient involvement, as the patient woke up from sleep with pain to the left shoulder and noticed the dressing around the port was leaking.The patient reported to the emergency room (er) and had experienced slight raised edema around the port.There was a medical intervention, chemotherapy infusion was stopped, removed the needle from the port, and flushed the port.The outcome of the event was the patient showed up to the er, four days after, with left shoulder and arm pain.Pain worse with movement and deep breaths.The port was removed by the surgeon.Patient date of birth is (b)(6) 1997.The date of event was on 3-apr-2025 and 7-apr-2025.

• 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: 21942927
• Report Number: 3012307300-2025-05115
• Device Sequence Number: 15549083
• Product Code: LJT
• UDI-Device Identifier: 10610586012594
• UDI-Public: (01)10610586012594(17)270605(10)4307473
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/01/2025
• 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 Age: 27 YR
• Patient Sex: Unknown