MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. DUOGLIDE DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 5625150

Device Problems Fluid/Blood Leak (1250); Material Fragmentation (1261)

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

Event Date 06/26/2021

Event Type  Injury  

Event Description

While attempting to inject ct contrast into dialysis catheter port, the tubing shredded and contrast went onto patient's pillow.Dr.Was called to replace dialysis catheter at bedside.Fda safety report id # (b)(4).

• Brand Name: DUOGLIDE DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC. ; salt lake city UT 84116
• MDR Report Key: 12107783
• MDR Text Key: 260069870
• Report Number: MW5102255
• Device Sequence Number: 1
• Product Code: MPB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2022
• Device Model Number: 5625150
• Device Catalogue Number: 220331
• Device Lot Number: REEX2989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 59