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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 CATHETER, STAINLESS STEEL ELECTRODES BIPOLAR ELECTRODE CATHETER

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C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, STAINLESS STEEL ELECTRODES BIPOLAR ELECTRODE CATHETER Back to Search Results
Model Number 006173P
Device Problem Pacing Problem
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 whenever the electrode catheter was touched or moved slightly it did not pace. The complainant reported that the device was then replaced and there were no further issues.

 
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Brand NameBALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, STAINLESS STEEL ELECTRODES
Type of DeviceBIPOLAR ELECTRODE 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
yonic anderson
8195 industrial blvd
covington , GA 30014
7707846100
MDR Report Key8283689
Report Number1018233-2019-00437
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Reporter Occupation
Report Date 06/10/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number006173P
Device Catalogue Number006173P
Device LOT NumberGFCX0509
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/06/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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