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

Model Number 303316A

Device Problems Inflation Problem (1310); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2020

Event Type  malfunction  

Event Description

Patient presented to the operating room for a hip surgery with urinary catheter not intact.Catheter was secure in stat lock during assessment before patient was moved to operating table.Catheter tip was not in the patient and the tip was sitting between patient's legs and inflation bulb was not intact.Attending md notified and urology was consulted for least invasive way to verify that the piece of rubber was not retained in the patient's body.

Event Description

Patient presented to the operating room for a hip surgery with urinary catheter not intact.Catheter was secure in stat lock during assessment before patient was moved to operating table.Catheter tip was not in the patient and the tip was sitting between patient's legs and inflation bulb was not intact.Attending md notified and urology was consulted for least invasive way to verify that the piece of rubber was not retained in the patient's body.

• Brand Name: BARDEX I.C. COMPLETE CARE 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: 11805423
• MDR Text Key: 249966183
• Report Number: 11805423
• 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
• Type of Report: Initial,Followup
• Report Date: 05/04/2021,12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 303316A
• Device Catalogue Number: 303316A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31390 DA