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

Catalog Number	21-4483-24
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: reason device not evaluated by mfg: other; device was not returned to manufacturer.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 is stated that the patient underwent an ultrasound-guided right internal jugular vein catheterization and right chest wall infusion port placement, and on the third day after surgery, there was local swelling and pain occurred at the incision of the part body.The patient was re-incised, and the wounds were re-cleaned and then underwent port implantation to implant a new one.
Additional Manufacturer Narrative
B1 and b2 corrected.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: one sample was received.A visual inspection found that only the port with a small portion of the catheter was received.It was observed the septum had previously been accessed and the housing had evidence of needle strikes.In attempts to replicate clinical use a needle attached to a syringe with 10 ml of black dye was used to access the port.No leakage was observed.The catheter was then accessed in the same manner and a small leak was observed from the catheter.Upon further inspection a tear like anomaly was observed.Roughly 180 degrees from the tear two puncture like anomalies were observed.The catheter was removed from the metal port and inspected.Indentations were observed roughly 180 degrees from each other.The damage observed being 180 degrees from each other in both the catheter and the port is typical of a hinged double sided tool interaction.The complaint of swelling and pain cannot be confirmed.However, during investigation, a leak was observed to be coming from a tear found in the catheter.The probable cause of the tear is due to a double-sided tool interaction during use.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• 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: 20866197
• Report Number: 9617604-2024-00920
• Device Sequence Number: 15661179
• Product Code: LJT
• UDI-Device Identifier: 10610586032776
• UDI-Public: (01)10610586032776(17)290206(10)4468585
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2025

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: 21-4483-24
• Device Lot Number: 4468585
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 11/13/2024; 03/04/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/05/2025; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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: 15 YR
• Patient Sex: Male