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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER Back to Search Results
Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the catheter was found expelled from the patient when the nurse moved the blankets.The catheter balloon was tested after being found.When 10cc of fluid was put in the balloon a hole was noticed that caused the fluid to leak out.No medical intervention reported.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.We were unable to review the labeling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.
 
Event Description
It was reported that the catheter was found expelled from the patient when the nurse moved the blankets.The catheter balloon was tested after being found.When 10 cc of fluid was put in the balloon a hole was noticed that caused the fluid to leak out.No medical intervention reported.
 
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Brand Name
LATEX FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8490007
MDR Text Key141312217
Report Number1018233-2019-01759
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received04/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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