MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL DELTEC POWER PORT-A-CATH II PORTS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4455-24
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical port-a-cath tray was rubbing where the clavicle is located on the patient.An x-ray was done to reveal a ten cm piece had remained in the patient upon removal of the device.The patient then had the catheter stump removed from the heart via the groin in the operation room.No further adverse effects reported.
Additional Manufacturer Narrative
Additional information received from the product return about the smiths medical device's lot number.
Additional Manufacturer Narrative
One power pac tray was returned for evaluation.Visual inspection of the device found a crack in the catheter.Production personnel perform visual inspections and patency tests on 100 percent of product to very the device has no leakage.A sample was taken to verify that parts were free from damage, as well as a patency test performed.After these reviews were conducted, it was determined the damgae to the device occurred after the product left the shm facitily.The most probably cause of the issue was unable to be confirmed; investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• Brand Name: SMITHS MEDICAL DELTEC POWER PORT-A-CATH II PORTS
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9084021
• Report Number: 3012307300-2019-05017
• Device Sequence Number: 2762820
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 03/20/2023
• Device Catalogue Number: 21-4455-24
• Device Lot Number: 3614513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 11/17/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/24/2019; 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention