MAUDE Adverse Event Report: BARD MEDICAL URINE METER DRAIN BAG; DRAIN BAG, FOLEY

Model Number 153204

Device Problem Material Separation (1562)

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

Event Date 04/24/2016

Event Type  malfunction  

Event Description

The urine meter from a bard temperature sensing foley sampling port came apart when syringe was attached to sample urine specimen.

• Brand Name: URINE METER DRAIN BAG
• Type of Device: DRAIN BAG, FOLEY
• Manufacturer (Section D): BARD MEDICAL; 8195 industrial boulevard; covington GA 30014
• MDR Report Key: 5837029
• MDR Text Key: 50885499
• Report Number: 5837029
• 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: 06/07/2016,07/22/2016

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: Nurse
• Device Model Number: 153204
• Device Lot Number: NGAQ1580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1