MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. POWER PORT-A-CATH II; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4452-24
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a material defect, and the customer had to explant the port and implant a new one.There was patient involvement and unknown patient harm.
Additional Manufacturer Narrative
B3: date of event is unknown.One photo was provided for the investigation.The reported problem could be seen within the photo.The compliant is confirmed.The root cause is unable to be determined.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Additional Manufacturer Narrative
H6: evaluation codes update.One device was received for investigation.The device was visually inspected and functionally tested.During the visual inspection it was found the catheter broken.The reported complaint is confirmed.The root cause is unknown.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: POWER PORT-A-CATH II
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21118146
• Report Number: 3012307300-2025-00518
• Device Sequence Number: 7680082
• Product Code: LJT
• UDI-Device Identifier: 10610586032677
• UDI-Public: (01)10610586032677(17)290222(10)4460623
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/23/2025

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: 21-4452-24
• Device Lot Number: 4460623
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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
• Patient Sex: Female