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U.S. Department of Health and Human Services

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

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C. R. BARD, INC. SURESTEP; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Catalog Number A942216
Device Problems Material Puncture/Hole (1504); Device Slipped (1584)
Patient Problem Urinary Retention (2119)
Event Date 11/12/2020
Event Type  malfunction  
Event Description
Foley was placed at beginning of procedure.The foley fell out in pacu and was found to have a hole in the balloon.The patient was unable to void using a bed pan.
 
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Brand Name
SURESTEP
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
C. R. BARD, INC.
1211 mary magnan blvd
madison GA 30650
MDR Report Key10991293
MDR Text Key220920173
Report Number10991293
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/23/2020
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 No Information
Device Catalogue NumberA942216
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2020
Event Location Hospital
Date Report to Manufacturer12/11/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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