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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. BARD SURESTEP FOLEY TRAY SYSTEM; CATHETER, RETENTION TYPE, BALLOON

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C.R. BARD, INC. BARD SURESTEP FOLEY TRAY SYSTEM; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number REF#A300416A
Device Problems Difficult to Remove (1528); Structural Problem (2506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
Event Type  malfunction  
Event Description
Urinary catheter was difficult to discontinue.The balloon was emptied completely prior to removal attempt, but resistance was noted to be present.Tube was advanced further and balloon rechecked to make sure all fluids were removed from balloon.There was noted to be a small ridge of silicone at the distal end of the catheter balloon, which is normally not present.Fda safety report id # (b)(4).
 
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Brand Name
BARD SURESTEP FOLEY TRAY SYSTEM
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
C.R. BARD, INC.
covington GA 30014
MDR Report Key11321390
MDR Text Key232189922
Report NumberMW5099357
Device Sequence Number1
Product Code EZL
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/09/2021
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 NumberREF#A300416A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/11/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age27 YR
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