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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER Back to Search Results
Model Number 006173P
Device Problem Material Fragmentation (1261)
Patient Problems Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2019
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 was broken.It was stated that the user was exposed to hazardous, blood, or bodily fluids.As per follow-up information received via ibc on 10feb2023, it was stated that the device was used on the patient and the patient was exposed to hazardous, blood, or bodily fluids.
 
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 was broken.It was stated that the user was exposed to hazardous, blood, or bodily fluids.As per follow-up information received via ibc on 10feb2023, it was stated that the device was used on the patient and the patient was exposed to hazardous, blood, or bodily fluids.
 
Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduced.The used temporary pacing electrode catheter was returned without the original packaging.No break or visible defects were noted on the catheter.The balloon successfully inflated with 1.5cc air using an in-house luer syringe and the stopcock.After 30 seconds the stopcock was opened and the balloon passively deflated returning the 1.5cc when the syringe was connected, meeting specifications.The device was used for treatment purposes.As the reported event is unconfirmed, dhr review and label/packaging review are 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 inspected.
 
Event Description
It was reported that the temporary pacing electrode catheter was broken.It was stated that the user was exposed to hazardous, blood, or bodily fluids.Per follow-up information received via ibc on (b)(6) 2023, stated that the device was used on the patient and the patient was exposed to hazardous, blood, or bodily fluids.
 
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Brand Name
BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
Type of Device
BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER
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 Key16435252
MDR Text Key310252308
Report Number1018233-2023-01166
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 Received02/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2020
Device Model Number006173P
Device Catalogue Number006173P
Device Lot NumberGFCR2402
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 Manufactured05/18/2018
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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