MAUDE Adverse Event Report: ST PAUL DELTEC POWER PORT-A-CATH II VENOUS ACCESS; PORT-CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCU

Model Number	21-4485-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the catheter attached to port chamber leaked.The leak was discovered during evaluation of implanted device in-situ via contrast injection.Sedation was provided, the defective assembly was removed and a new device was installed.No patient injury.
Additional Manufacturer Narrative
Device evaluation: one device was returned for investigation.Visual inspection found a cut was identified on the catheter, confirming the complaint.A leak was detected during functional testing.A root cause cannot be associated with manufacturing process since the failure could not be reproduced following assembly process.The most probable root cause was that the damage occurred after the product left the manufacturing facilities.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No corrective actions are required since the root cause could not be attributed to the manufacturing process.

• Brand Name: DELTEC POWER PORT-A-CATH II VENOUS ACCESS
• Common Device Name: PORT-CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCU
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16672738
• Report Number: 3012307300-2023-03459
• Device Sequence Number: 15047669
• Product Code: LJT
• UDI-Device Identifier: 10610586032790
• UDI-Public: 10610586032790
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 21-4485-24
• Device Catalogue Number: 21-4485-24
• Device Lot Number: 4139531
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 07/22/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 06/27/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown