MAUDE Adverse Event Report: ST PAUL DELTEC POWER PORT-A-CATH II PORTS; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVA

Model Number	21-4475-24
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device failed to insert due to high port profile during the l port insertion process.No additional information.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.On sample was received in the decontaminated conditions without its original packaging.Visual inspection was performed at 12 inches under normal lighting to received unit.According to the visual inspection, it could be observed that the catheter and port are in good condition, no discrepancies affecting their functioning were detected.During the functional testing the catheter was connected to the port to reproduce the failure mode or find an unusual function; then was pulled to verify if the catheter could detach easily; the sleeve was displaced to the top of the tube and compressed, the sleeve prevent catheter detach.No discrepancies were detected, the catheter kept on the port after pulling it.Root cause cannot be determined since the complaint was not confirmed.

• Brand Name: DELTEC POWER PORT-A-CATH II PORTS
• Common Device Name: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; rm401, (gems bldg, gunja-dong); minneapolis, MN 55442
• MDR Report Key: 13453464
• Report Number: 3012307300-2022-02557
• Device Sequence Number: 6009513
• Product Code: LJT
• UDI-Device Identifier: 10610586039973
• UDI-Public: 10610586039973
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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 Expiration Date: 06/23/2025
• Device Model Number: 21-4475-24
• Device Catalogue Number: 21-4475-24
• Device Lot Number: 4036935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown