MAUDE Adverse Event Report: ST PAUL DELTEC; SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION

Model Number	21-4083-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the position of the capsule after the fluid replacement was swollen.After the catheter was removed, leakage was found by angiography, the doctor replaced the ports.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.The device passed all functional tests.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: DELTEC
• Common Device Name: SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION
• 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; minneapolis, MN 55442
• MDR Report Key: 12407492
• Report Number: 3012307300-2021-09045
• Device Sequence Number: 14498438
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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
• Device Model Number: 21-4083-24
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 4073104
• 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: 08/02/2021
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• 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
• Patient Sex: Unknown