MAUDE Adverse Event Report: C.R. BARD, INC. BARD; COUDE, CATHETER

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

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

Event Date 03/21/2019

Event Type  Injury  

Event Description

Patient had surgery with a foley catheter and ureteral stents placed.On post-operative day 1, the foley catheter balloon ruptured, allowing the catheter to come out.Patient had to return to the operating room to have foley and stents replaced.

• Brand Name: BARD
• Type of Device: COUDE, CATHETER
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 8471217
• MDR Text Key: 140729573
• Report Number: MW5085472
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 87