MAUDE Adverse Event Report: CR BARD, INC. FOLEY CATHETER

Model Number 303316A

Device Problems Deflation Problem (1149); Hole In Material (1293); Device Dislodged or Dislocated (2923)

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

Event Date 04/25/2016

Event Type  malfunction  

Event Description

During pt assessment, foley catheter found dislodged and laying on pt's leg.Balloon deflated and small hole was noticed on the catheter just below the balloon.

• Brand Name: FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): CR BARD, INC. ; covington GA 30014
• MDR Report Key: 5628391
• MDR Text Key: 44348357
• Report Number: MW5062046
• Device Sequence Number: 1
• Product Code: EZL
• 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: 04/28/2016

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: 303316A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR