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

Catalog Number	21-4083-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: 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 after the infusion port was implanted on the patient, the port membrane leaked.No adverse effects have been reported.
Additional Manufacturer Narrative
One device was returned for analysis.Visual inspection showed the device was contaminated.There was no evidence to review in the device's event history log.A functional test was perfomed and the reported issue was not duplicated.The cause of the reported issue was unknown.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.D4: (b)(4).(b)(6).

• Brand Name: DELTEC PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS
• 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: 17515607
• Report Number: 3012307300-2023-08073
• Device Sequence Number: 5562174
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: 10610586023613
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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 Catalogue Number: 21-4083-24
• Device Lot Number: 4256921
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/01/2023
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2022
• 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