MAUDE Adverse Event Report: C. R. BARD, INC. LUBRI-SIL I.C. COMPLETE CARE TEMP-SENSING FOLEY CATHETER TRAY AND URINE METER; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number 319516AM

Device Problem Material Rupture (1546)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/08/2021

Event Type  malfunction  

Event Description

Catheter was inserted and made a 'u-turn' back outside of patient, balloon was ruptured.Patient had significant bleeding.Neuro md notified, who then attempted to place coude without success.Urology was consulted and this person placed a regular foley catheter.

• Brand Name: LUBRI-SIL I.C. COMPLETE CARE TEMP-SENSING FOLEY CATHETER TRAY AND URINE METER
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12623103
• MDR Text Key: 276143376
• Report Number: 12623103
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319516AM
• Device Catalogue Number: 319516AM
• Device Lot Number: BGFS1387
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2021
• 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: 24090 DA
• Patient Weight: 110