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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
Catalog Number UNKNOWN
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Injury (2348)
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 a mucosal membrane pressure injury on penis during the use of a foley catheter.Complainant also stated that the catheter length was too short which doesn't allow for slack externally and was causing tension/ pressure on penis.
 
Manufacturer Narrative
Per additional information received bard/bd has determined that is not a reportable event h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
 
Event Description
It was reported that the patient experienced a mucosal membrane pressure injury on penis during the use of a foley catheter.Complainant also stated that the catheter length was too short which doesn't allow for slack externally and was causing tension/pressure on penis.Per email received from the complainant on 18jul2020, the foley catheter was not removed from the patient and the patient was discharged from the hospital with the catheter in place due to bph, failed voiding trials and urinary retention.Treatment for the skin included rotating stat locks to alleviate pressure, performing routine catheter care bid and applying bacitracin to the urethral meatus.The patient had an elongated urethra and the 17 inch catheter left only one inch external for securing the device.This was believed to have caused strain on the meatus resulting in pressure and the mucosal membrane injury.
 
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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 Key10288703
MDR Text Key199985490
Report Number1018233-2020-04605
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,use
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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