MAUDE Adverse Event Report: ST PAUL DELTEC PORT-A-CATH P.A.S. PORT ELITE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Model Number 21-4590-24

Device Problems Fluid/Blood Leak (1250); Radiation Leak (1357); Infusion or Flow Problem (2964)

Patient Problem Swelling/ Edema (4577)

Event Date 03/03/2023

Event Type  Injury  

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 required.

Event Description

It was reported that the nurse found that the patient's neck was significantly swollen during the infusion of chemotherapy drugs, and the chemotherapy drugs leaked out.The connection of the port catheter was ruptured which shown by contrast agent during the digital subtraction angiography (dsa) at the radiology department.The device was then immediately removed.

• Brand Name: DELTEC PORT-A-CATH P.A.S. PORT ELITE
• Type of Device: 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: 16791926
• MDR Text Key: 313801196
• Report Number: 3012307300-2023-04410
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586021541
• UDI-Public: 10610586021541
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 21-4590-24
• Device Catalogue Number: 21-4590-24
• Device Lot Number: 4227823
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female