MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY; CATHETER, RETENTION TYPE, BALLOON

Model Number A942216

Device Problems Break (1069); Unintended Deflation (4061)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/01/2023

Event Type  malfunction  

Event Description

Indwelling catheter fell out after patient was in prone position.Upon inspection of catheter, tip of catheter ripped off causing the balloon to deflate and catheter to fall out.Balloon still intact, approximately 1cm of the tip of the catheter is missing.No blood noted on catheter to indicate any trauma.Catheter was not tugged on or pulled during positioning.Tip not found on initial assessment of area.Doctors were made aware.Plan to inspect the meatus after the case when patient is supine per doctor, notified urology is unable to found broken tip.Nurse manager notified of event and updated on plan of care regarding the missing catheter tip.Catheter lot information saved, and product failure form completed.Neuro csl aware as well.Urology consult paged and intraoperative cysto completed to rule out foreign body.Cysto was negative for foreign body.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 17030119
• MDR Text Key: 316211693
• Report Number: 17030119
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: A942216
• Device Catalogue Number: A942216
• Device Lot Number: NGGZ1611
• 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: 05/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male