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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. LUBRI-SIL I.C. COMPLETE CARE ALL-SILICONE FOLEY CATHETER TRAY AND URINE METER; CATHETER, RETENTION TYPE, BALLOON
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C. R. BARD, INC. LUBRI-SIL I.C. COMPLETE CARE ALL-SILICONE FOLEY CATHETER TRAY AND URINE METER; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number 303416A
Device Problems Leak/Splash (1354); Defective Component (2292); Device Fell (4014)
Patient Problem Insufficient Information (4580)
Event Date 08/04/2021
Event Type  malfunction  
Event Description
Patient had foley catheter in place.Rn had been monitoring hourly urine output in the immediate post-operative period.At approximately 2200, rn noticed a decrease in uop, but amount was adequate.When rn rechecked uop at 2300, uop was 0.Rn called urology tech to bedside to attempt irrigation of foley catheter.Upon attempt to irrigate, foley fell out of patient without balloon being deflated.Service was notified and orders were obtained to replace foley catheter.Rn used 10cc leur-lock syringe on catheter that had fallen out and found that the balloon was defective & leaking, leading to deflation of the balloon.
 
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Brand Name
LUBRI-SIL I.C. COMPLETE CARE ALL-SILICONE FOLEY CATHETER TRAY AND URINE METER
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
C. R. BARD, INC.
8195 industrial blvd
covington GA 30014
MDR Report Key12420914
MDR Text Key269792998
Report Number12420914
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 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number303416A
Device Catalogue Number303416A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2021
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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