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

Catalog Number A942216

Device Problems Material Puncture/Hole (1504); Device Slipped (1584)

Patient Problem Urinary Retention (2119)

Event Date 11/12/2020

Event Type  malfunction  

Event Description

Foley was placed at beginning of procedure.The foley fell out in pacu and was found to have a hole in the balloon.The patient was unable to void using a bed pan.

• Brand Name: SURESTEP
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 1211 mary magnan blvd; madison GA 30650
• MDR Report Key: 10991293
• MDR Text Key: 220920173
• Report Number: 10991293
• 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: 11/23/2020

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: No Information
• Device Catalogue Number: A942216
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other