DISPOZ-A-BAG *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-06 for DISPOZ-A-BAG * manufactured by Bard Access Systems.

Event Text Entries

[15698852] Patient had a ventral hernia repaired and was discharged home in stable condition. She contacted the facility less than three months after the event and returned to the emergency department with complaints of urinary retention. Bard foley catheter placed in emergency department by the rn and 1,000cc of urine was drained and patient felt much better. Bard leg bag was attached by the rn and the patient was discharged home with foley and leg bag in place. When patient woke the next morning and had no urine output in the bag, she stated that she needed to seek additional care at another facility. Patient had the urge to urinate, but was unable to do so. At the other facility, it was discovered that the urine leg bag had been put on 'upside down'. The foley catheter had been connected incorrectly to the urine leg bag; it was mistakenly attached to the outflow (flip-flo) valve instead of the inlet valve. When corrected, urine flowed and patient felt better again. No further medical intervention needed. No harm to patient. Patient denies removing the leg bag from the foley after it was connected on the first emergency department visit and rn does not recall that she put the device on backwards, but noted that the foley catheter easily fit on both the inlet and the flip-flo valves. No devices or packaging are available from this patient's experience. Unknown what size catheter or retention balloon were used. No other product information is available on the foley.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number733483
MDR Report Key733483
Date Received2006-07-06
Date of Report2006-07-06
Date of Event2006-04-04
Report Date2006-07-06
Date Reported to FDA2006-07-06
Date Added to Maude2006-07-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDISPOZ-A-BAG
Generic NameFOLEY BAG
Product CodeEYZ
Date Received2006-07-06
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key721605
ManufacturerBARD ACCESS SYSTEMS
Manufacturer Address5425 WEST AMELIA EARHART DRIVE SALT LAKE CITY UT 84116 US


Patients

Patient NumberTreatmentOutcomeDate
10 2006-07-06

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