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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 TEMPERATURE PACING ELECTRODE
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C.R. BARD, INC. (COVINGTON) -1018233 TEMPERATURE PACING ELECTRODE Back to Search Results
Model Number 006173P
Device Problem Burst Container or Vessel (1074)
Patient Problems Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
Event Type  Injury  
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 temporary pacing electrode catheter balloon was burst.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: b, d, f, h h11: section a through f - the information provided by bd represents all 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.
 
Event Description
It was reported that the temporary pacing electrode catheter balloon was burst.Also stated that the user was exposed to hazardous, blood, or bodily fluids.It was unknown what medical intervention was given.
 
Manufacturer Narrative
The reported event is unconfirmed as the problem could not be reproduced.The used temporary pacing electrode catheter was returned with the attached syringe and no original packaging.No visible defects were noted on the catheter.The balloon was successfully inflated with 1.5cc air using the returned luer syringe.No visible deflation was noted after 30 seconds and about 1.2cc air returned when passively deflated.The inflated balloon was viewed under the microscope at 5x magnification and no signs of a burst were noted, the device was within specifications.The device was used for treatment purposes.As the reported event is unconfirmed, a dhr review and a label/packaging review is not required.H11: section a through f - the information provided by bd represents all 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 actual/suspected device was evaluated.
 
Event Description
It was reported that the temporary pacing electrode catheter balloon was burst.Also stated that the user was exposed to hazardous, blood, or bodily fluids.It was unknown what medical intervention was given.
 
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Brand Name
TEMPERATURE PACING ELECTRODE
Type of Device
TEMPERATURE PACING ELECTRODE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key16427487
MDR Text Key310245403
Report Number1018233-2023-01128
Device Sequence Number1
Product Code LDF
UDI-Device Identifier00801741011207
UDI-Public(01)00801741011207
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K800298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Model Number006173P
Device Catalogue Number006173P
Device Lot NumberGFFR0520
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2021
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) Other;
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