MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORT-A-CATH IMPLANTABLE ACCESS SYSTEM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4483-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Codes	Extravasation (1842); Localized Skin Lesion (4542)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an extravasation due to a double tear, 10cm from the port chamber.The patient developed sub clavicular swelling, plus infection as part of the follow-up, small extravasation, not excluding the chemotherapy.The first symptom developed on (b)(6) 2024.The event occurred during chemotherapy and the product was handled by the personnel.The port was changed on (b)(6) 2025 and another one was installed for the residual infection.As a result of the incident, the patient was subjected to topical open wound treatment, port removal, ab-therapy and was admitted to the (b)(6) hospital between (b)(6) 2025.The event caused a delay in the palliative chemotherapy.
Additional Manufacturer Narrative
E1 phone number: (b)(6).B3: date of event is unknown; no information has been provided to date.H3, other: device has not been returned to date.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
No device was received for investigation.Therefore, we are unable to determine the reported complaint.If we receive the device, we will reopen the investigation for further evaluations.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• 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: 21333388
• Report Number: 9617604-2025-00109
• Device Sequence Number: 7865851
• Product Code: LJT
• UDI-Device Identifier: 10610586032776
• UDI-Public: (01)10610586032776(17)281013(10)4434248
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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?: Yes
• Operator of Device: Other
• Device Catalogue Number: 21-4483-24
• Device Lot Number: 4434248
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown