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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); Positioning Problem (3009)
Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
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 medical staff could not get a luer lock syringe into the tip of the port to remove the fluid from the balloon.A needle had to be used to remove the saline and deflate the balloon.
 
Event Description
It was reported that medical staff could not get a luer lock syringe into the tip of the port to remove the fluid from the balloon.A needle had to be used to remove the saline and deflate the balloon.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.
 
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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 Key8312301
MDR Text Key135229553
Report Number1018233-2019-00686
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 health professional,other
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Date Manufacturer Received02/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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