MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX® ALL-SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 165818

Device Problems Hole In Material (1293); Leak/Splash (1354); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2018

Event Type  malfunction  

Event Description

Foley catheter (18fr.Silicone) slipped out of patient when applying leg strap.The foley was tested to check for any leaks in the balloon and it was found to have holes in it.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial boulevard; covington GA 30014
• MDR Report Key: 7540246
• MDR Text Key: 109126004
• Report Number: 7540246
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 165818
• Device Catalogue Number: 165818
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR