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

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2022

Event Type  malfunction  

Event Description

Nurse was irrigating the patient¿s suprapubic catheter and accidentally over flushed the balloon port, causing the balloon to rupture.The nurse misidentified the balloon port as a flush port.Patient had a leg bag on instead of a typical large foley bag.Unknown to the nurse, the leg bag does not have a flush port while the large foley bag does.The flush port on the large foley bag is near the balloon port.This difference in design contributed to the nurse misidentifying the balloon port as the flush port.Patient had to return to surgery for replacement of the catheter and to check bladder for any balloon fragments.

• Brand Name: BARD FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 15275267
• MDR Text Key: 298403340
• Report Number: 15275267
• Device Sequence Number: 1
• Product Code: EZL
• 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: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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 the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18250 DA
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Hispanic