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U.S. Department of Health and Human Services

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

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C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2017
Event Type  malfunction  
Event Description
10ml of normal saline injected by physician and found that the foley balloon had a leak.
 
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Brand Name
SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
C. R. BARD, INC.
8195 industrial blvd
covington GA 30014
MDR Report Key9289595
MDR Text Key165405671
Report Number9289595
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 Risk Manager
Type of Report Initial
Report Date 10/10/2019,02/14/2017
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2019
Date Report to Manufacturer11/07/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age22265 DA
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