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Adverse Event Report

C.R. BARD, INC. BARDEX ROBINSON CATHETER URETHRAL CATHETER   back to search results
Catalog Number 056012
Device Problem Intraprocedure, fire or flash during
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A urological catheter caught fire while being used for retraction during a tonsillectomy procedure. Cautery was being used in an oxygen-enriched environment for tonsillectomy and catheter was being used for retraction. There was a flame during the procedure. Cautery tip and catheter were both charred and pt sustained burns to oral cavity.

 
Manufacturer Narrative

Urethral catheters are designed for urological use and are labeled accordingly. When rubber products are exposed to intense heat, they can produce flames that quickly subside when the heat source is removed. A black smoke and strong rubber smell remain once the flames subside. The event resulted from off-label use which consisted of exposing a rubber product to intense heat resulting in the catheter emitting flames.

 
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Brand NameBARDEX ROBINSON CATHETER
Type of DeviceURETHRAL CATHETER
Baseline Brand NameBARDEX ROBINSON CATHETER
Baseline Generic NameURETHRAL CATHETER
Baseline Catalogue Number056012
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
C.R. BARD, INC.
8195 industrial blvd.
covington GA 30014
Manufacturer (Section D)
C.R. BARD, INC.
8195 industrial blvd.
covington GA 30014
Manufacturer Contact
vivian stephens, mgr
8195 industrial blvd.
covington , GA 30014
(770) 784 -6902
Device Event Key454588
MDR Report Key465645
Event Key441278
Report Number1018233-2003-00024
Device Sequence Number1
Product CodeKOD
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/11/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number056012
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Ageunk
Event Location Hospital
Date Manufacturer Received05/12/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/11/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,CAUTERY INSTRUMENT.,

Database last updated on January 30, 2009

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