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

Model Number 21-4475-24

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

It was reported that the port connector is defective.No additional information.

• Brand Name: DELTEC POWER PORT-A-CATH II PORTS
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 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: 13453297
• MDR Text Key: 287526143
• Report Number: 3012307300-2022-02554
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586039973
• UDI-Public: 10610586039973
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-4475-24
• Device Catalogue Number: 21-4475-24
• Device Lot Number: 3899233
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1