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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 Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)
Patient Problems Patient Problem/Medical Problem (2688); 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 patient experienced bleeding with the use of the foley catheter because it was too small.No medical intervention was reported.
 
Event Description
It was reported that the patient experienced bleeding with the use of the foley catheter because it was too small.No medical intervention was reported.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure mode could be wrong product size selected/speed controller faulty/mix product(catheter).The lot number is unknown; therefore, the device history record could not be reviewed.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.
 
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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 Key9775742
MDR Text Key185257446
Report Number1018233-2020-01457
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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