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	21-4453-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Extravasation (1842); Necrosis (1971); Tissue Breakdown (2681)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the operation it was discovered that the catheter had a small hole at the transition to the ventricle.There was patient involvement.The patient details: 57 years old, gender: male.It was reported that the patient experienced extravasation of chemotherapeutic agent (oxaliplatin) into the right deltoideopectoral region.There was port explantation with lavage on (b)(6) 2024 with intended secondary wound healing.The patient also experienced tissue necrosis caused by the long effect of the toxicity of the chemotherapy drug.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
A3a - sex, d1 - brand name: correction.D9: date returned to mfg.: 3/17/2025.H3 and h6.Codes: updated.Updated device evaluation: one used device sample was received.During visual inspection damage was noticed around the base of the device where the tubing meets the transition to the ventricle.Confirmed the customer complaint of a pin hole.Probable cause, unintentional bending force, causing tubing to tear.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: 21229476
• Report Number: 3012307300-2025-01069
• Device Sequence Number: 8285366
• Product Code: LJT
• UDI-Device Identifier: 10610586032684
• UDI-Public: (01)10610586032684(17)280911(10)4426424
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072657
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2025

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: Health Professional
• Device Catalogue Number: 21-4453-24
• Device Lot Number: 4426424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/05/2025; 03/28/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/06/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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: Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male