MAUDE Adverse Event Report: BARD MEDICAL LUBRI-SIL I.C. FOLEY CATHETER

Model Number 303416A

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/20/2017

Event Type  malfunction  

Event Description

Bard, lubri-sil i.C.Complete care 16 fr.Foley catheter was not draining.When investigated, it was discovered that the catheter was not secure.Upon further evaluation when the catheter was able to be evaluated, a hole was discovered in the retention balloon.

• Brand Name: LUBRI-SIL I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): BARD MEDICAL; covington GA 30014
• MDR Report Key: 7057390
• MDR Text Key: 92977365
• Report Number: MW5073552
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 303416A
• Device Catalogue Number: 303416A
• Device Lot Number: 1758SI16
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR