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

Model Number 0167SI22

Device Problems Deflation Problem (1149); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 05/13/2021

Event Type  malfunction  

Event Description

A size 22fr 30cc/ml 3 way foley catheter was inserted as part of the procedure.Foley cath stopped flowing before procedure ended.Flushed for clots and adjusted but continued to not flow.Balloon cuff would not deflate.Catheter was removed by maneuvering and replaced with the same type.

• Brand Name: BARDEX I.C. FOLEY CATHETER
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11900383
• MDR Text Key: 253138694
• Report Number: 11900383
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0167SI22
• Device Catalogue Number: 0167SI22
• Device Lot Number: NGFP0549.
• 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: 05/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 99