MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC (DBA MEDCOMP) DUO-FLOW; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number MCDLT4400

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 03/06/2018

Event Type  malfunction  

Event Description

The patient presented to the dialysis unit for routine scheduled dialysis.Treatment complete without issue.During the return of blood from the circuit to the patient a leak was noted on the venous (blue) port of the hd catheter were the blue hub sits inside clear rubber tubing.Staff clamped above and below the leak.All blood was safely returned without complications through the arterial port.Surgery was consulted and repaired the line.The line had been originally inserted approximately 4 months earlier.Nephrology attending physician consulted.Antibiotics were prescribed prophylactically.Blood cultures where drawn at the time of the leak as well as approximately 3 days later.Both sets of cultures were negative.Ciprofloxacin and vancomycin were prescribed and administered.Review of case -- point of leakage may be due to catheter bending at that site due to patient's habitus.Will continue to monitor catheter in future treatments.

• Brand Name: DUO-FLOW
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDICAL COMPONENTS, INC (DBA MEDCOMP); 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7402303
• MDR Text Key: 104566424
• Report Number: 7402303
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2018

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 Operator: Nurse
• Device Expiration Date: 03/31/2018
• Device Model Number: MCDLT4400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2018
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 03/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DIALYSIS; NO
• Patient Age: 12 YR
• Patient Weight: 51