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

Model Number	21-4475-24
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the port connector is defective.No additional information.
Event or Problem Description
It was reported that the port connector is defective.No additional information.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.The sample returned; it consists of two unit.No sample returned for lot for one of the reported lots.The returned samples were received in the decontaminated conditions without its original packaging.The complainant returned units were visually inspected at a distance of 12 to 16 inches under normal conditions of illumination according to procedure.It could be observed that the catheter and port or both samples were in good condition, no discrepancies affecting their functioning were detected.Functional test was performed on the samples without the catheter trapped according information for use 1, the catheter was connected to the port in order to reproduce the failure mode or find an unusual function; then was pull in order 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 on both cases.No discrepancies were detected, the catheters kept on the port after pulling it.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No corrective actions are required.

• Brand Name: DELTEC POWER PORT-A-CATH II PORTS
• Common Device Name: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS
• 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: 13453394
• Report Number: 3012307300-2022-02555
• Device Sequence Number: 14925779
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: 11/24/2024
• Device Model Number: 21-4475-24
• Device Catalogue Number: 21-4475-24
• Device Lot Number: 3910084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• 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: 02/14/2023
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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