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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NBIH¿ TEMPORARY PACING ELECTRODE CATHETER BIPOLAR PACING ELECTRODE CATHETER

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C.R. BARD, INC. (COVINGTON) -1018233 NBIH¿ TEMPORARY PACING ELECTRODE CATHETER BIPOLAR PACING ELECTRODE CATHETER Back to Search Results
Model Number 007153P
Device Problems Pacing Problem (1439); Failure to Power Up (1476)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2019
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 the bipolar pacing electrode catheter would not power up, and the hose was changed but the device still did not work. Another probe was used on the patient to complete the procedure but the procedure was delayed and the patient was in a delicate state. Per additional information from the ibc via email 09jan2020, the device would not produce an electrical current or pace. The patient did not require additional sedatives or medication to maintain cardiac output while the electrodes were switched out.

 
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Brand NameNBIH¿ TEMPORARY PACING ELECTRODE CATHETER
Type of DeviceBIPOLAR PACING 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 Key9653526
MDR Text Key183167696
Report Number1018233-2020-00684
Device Sequence Number1
Product Code LDF
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number007153P
Device Catalogue Number007153P
Device LOT NumberGFDW1815
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/19/2019
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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