MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX ALL-SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 12 CH/FR (4.0MM) 5CC RIBBED BALL

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

Event Type  Injury  

Event Description

While the nurse was irrigating through the urinary drainage bag port, both patient and nurse heard a faint "pop".It was then determined that the catheter balloon had broken.Fda safety report id# (b)(4).

• Brand Name: BARDEX ALL-SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 10419649
• MDR Text Key: 203490349
• Report Number: MW5096096
• Device Sequence Number: 1
• Product Code: EZL
• 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: 08/13/2020

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: Health Professional
• Device Model Number: 12 CH/FR (4.0MM) 5CC RIBBED BALL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2020
• 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): Hospitalization
• Patient Age: 13 YR
• Patient Weight: 35