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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 Problem Inaccurate Flow Rate (1249)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the nurse had concern about the foley catheters as they were vapor locking.It was further stated that the foley catheter did not drain properly.So the nurse suggested to break the seal and place another bag.
 
Event Description
It was reported that the nurse had concern about the foley catheters as they were vapor locking.It was further stated that the foley catheter did not drain properly.So the nurse suggested to break the seal and place another bag.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.Potential root cause for this failure mode could be user related (example: salt accumulation)/block drainage lumen/no drainage eye/eye not centered).The lot number was unknown; therefore, the device history record could not be reviewed.Unable to review the labelling due to unknown product code.Although the product family was unknown, the foley catheter ifus are found to be adequate based on past reviews.The device was not returned.
 
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Brand Name
LATEX FOLEY CATHETER
Type of Device
LATEX FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11957814
MDR Text Key254854522
Report Number1018233-2021-03286
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 company representative,other
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
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 Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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