MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC TITANIUM PORT-A-CATH, LOW PROFILE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4083-24
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Extravasation (1842); Swelling/ Edema (4577)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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.
Event or Problem Description
It was reported that a 69-year-old-male patient in the department of radiotherapy for abdominal tumors experienced a 10cm 8cm swelling with tenderness appeared around the infusion port.The skin color around the infusion port was normal, and the skin temperature was normal.The reporter noted that the patient had an infusion port inserted on (b)(6) 2023 and had experienced no reactions for more than a year of use.On (b)(6) 2025, the patient's infusion port was fixed and unobstructed and blood could be drawn back.Anti-tumor pretreatment was performed at 9:59 without any special discomfort.At 16:38, 500ml of 5% glucose injection plus 130mg of oxaliplatin injection was intravenously infused for anti-tumor treatment and the patient reacted 10 minutes later.The infusion was stopped immediately, and the attending physician and nursing team leader were notified, and the patient was advised to rest in bed.After the acting head nurse consulted with the experts of the intravenous therapy specialist team, the needle was removed after blood was returned through the original needle, the site and range of the extravasation were recorded, and lidocaine + dexamethasone injection was given for local drug blockade treatment as ordered by the doctor, and the patient was covered with a transparent convalescent patch.At the same time, the anesthesiology department was consulted to assist in the treatment, and the handover was done well.The local skin changes of the patient's infusion port were closely observed, and the patient was advised to rest in bed and avoid strenuous exercise.The patient was comforted and provided with psychological counseling.
Additional Manufacturer Narrative
The device history record for the suspect device was reviewed.No discrepancies or anomalies were observed during the manufacturing of this lot.The suspect device was not returned for evaluation.Without the return of the samples the reported malfunction could not be confirmed, and a probable cause was unable to be determined.

• Brand Name: DELTEC TITANIUM PORT-A-CATH, LOW PROFILE
• Common Device Name: PORT AND 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: 22287819
• Report Number: 3012307300-2025-07296
• Device Sequence Number: 21051790
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: (01)10610586023613(17)280508(10)4405004
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: Health Professional
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 4405004
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male