MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. DECATHLON DF LONG-TERM HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number DF19SH24K

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2023

Event Type  malfunction  

Event Description

While tunneling the dialysis catheter, it broke away from the tunneler and would not stay on.There was patient contact, but no harm done.A new catheter kit was used to complete the procedure.

• Brand Name: DECATHLON DF LONG-TERM HEMODIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 17197854
• MDR Text Key: 317871291
• Report Number: 17197854
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DF19SH24K
• Device Catalogue Number: DF19SH24K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2023
• Date Report to Manufacturer: 06/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male