MAUDE Adverse Event Report: C.R. BARD, INC. SURESTEP; CATHETER, INDWELLING URETHRAL

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/25/2018

Event Type  malfunction  

Event Description

The balloon detached from the foley and was retained in the bladder.

• Brand Name: SURESTEP
• Type of Device: CATHETER, INDWELLING URETHRAL
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7641549
• MDR Text Key: 112477245
• Report Number: 7641549
• Device Sequence Number: 1
• Product Code: FCN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2018
• Date Report to Manufacturer: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10950 DA