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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SPECIALTY FOLEYS; TEMP SENSING CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 SPECIALTY FOLEYS; TEMP SENSING CATHETER Back to Search Results
Device Problems Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
 
Event Description
It was reported that the catheter was too stiff, which allegedly caused the catheter to go through the posterior wall of the urethra during insertion.The tissue damage that was observed was an opening in the posterior urethral wall with an extra urethral cavity present due to inflation of the foley catheter balloon in that location.A flexible cystoscopy was performed where a scope was passed anterior to the tissue damage and into the bladder using a guidewire.The scope was removed and an 18 french council tip catheter was passed over this wire and into the bladder without difficulty.Initially the returned urine was somewhat bloody, but turned clear.The physician believed that the tissue damage was caused by the catheter being too stiff.The patient was undergoing an aortic valve replacement and had no prior urologic history.
 
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 temperature sensing catheter product ifus are found to be adequate based on past reviews.(b)(4).The device was not returned.
 
Event Description
It was reported that the catheter was too stiff, which allegedly caused the catheter to go through the posterior wall of the urethra during insertion.The tissue damage that was observed was an opening in the posterior urethral wall with an extra urethral cavity present due to inflation of the foley catheter balloon in that location.A flexible cystoscopy was performed where a scope was passed anterior to the tissue damage and into the bladder using a guidewire.The scope was removed and an 18 french council tip catheter was passed over this wire and into the bladder without difficulty.Initially the returned urine was somewhat bloody, but turned clear.The physician believed that the tissue damage was caused by the catheter being too stiff.The patient was undergoing an aortic valve replacement and had no prior urologic history.
 
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Brand Name
SPECIALTY FOLEYS
Type of Device
TEMP SENSING CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7300862
MDR Text Key101118796
Report Number1018233-2018-00606
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age36 YR
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