MAUDE Adverse Event Report: BARD BARD; URINE METER FOLEY

Model Number NGXJ4043

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 02/18/2014

Event Type  malfunction  

Event Description

Foley was placed in pt intact.At 1300 wife complained that foley was leaking.Checked balloon appeared broken.

• Brand Name: BARD
• Type of Device: URINE METER FOLEY
• Manufacturer (Section D): BARD; covington GA 30014
• MDR Report Key: 3788339
• MDR Text Key: 4444663
• Report Number: MW5035870
• Device Sequence Number: 1
• Product Code: EXR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2014

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 Expiration Date: 03/01/2016
• Device Model Number: NGXJ4043
• Device Lot Number: 902916
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1