MAUDE Adverse Event Report: C.R. BARD, INC. BARD STATLOCK CATHETER STABILIZATION DEVICE; HOLDER, URETERAL CATHETER

Lot Number JUGT8542

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964); Material Split, Cut or Torn (4008)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

Found that the clamp on the extension set had made a cut in the extension set tubing which caused the iv to back up and leak.Rn replaced the extension set.This was a statlock catheter stabilization device: lot jugt8542, by bard.Fda safety report id# (b)(4).

• Brand Name: BARD STATLOCK CATHETER STABILIZATION DEVICE
• Type of Device: HOLDER, URETERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 15633099
• MDR Text Key: 302120140
• Report Number: MW5112736
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: JUGT8542
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American