MAUDE Adverse Event Report: ST PAUL DELTEC TITANIUM PORT-A-CATH, LOW PROFILE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Model Number	21-4083-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that the tubing was found damaged causing leakage.The port had been implanted in the patient for about 1.5 year.The product was removed by surgery.At that time, the tubing was found separated from port.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Device evaluation: one photo was received for investigation.The photo shows the catheter covered in blood inside a plastic bag; the catheter is observed to be broken from the proximal side at the connection between the port and catheter.No other damage or dysfunctional conditions are observed.The broken catheter evidently will cause a leak in the system.The reported failure mode, leaking, was confirmed.No product sample was received; therefore functional testing could not be completed.A root cause could not be identified.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 taken at this time.This failure will continue to be monitored to determine if new actions need to be taken.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: DELTEC TITANIUM PORT-A-CATH, LOW PROFILE
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17317964
• Report Number: 3012307300-2023-07186
• Device Sequence Number: 6226338
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: 10610586023613
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K942024
• 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): 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?: No
• Operator of Device: Other
• Device Expiration Date: 01/24/2025
• Device Model Number: 21-4083-24
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 3996278
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 07/22/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown