FDA Adverse Event Injury Summary report: N

HI-LO TRACHEAL TUBE

MDR report key: 3653 · Received July 9, 1992

Report

Report Number: 3653
Event Type: Injury
Date Received: July 9, 1992
Date of Event: February 4, 1992
Report Date: February 18, 1992
Manufacturer: MALLINCRODT CRITICAL CARE
Product Code: BTR
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

A TRACHEOSTOMY WAS BEING PERFORMED ON THIS PATIENT. THE PHYSICIAN WAS USING A BOVIE ELECTROCAUTERY DEVICE MANUFACTURED BY ASPEN TO CUT THROUGH THE TISSUES OF THE NECK. AS THE TRACHEA WAS OPENED, THE TIP OF THE ENDOTRACHEAL TUBE CUT FIRE. ALTHOUGH THE FLAMES WERE IMMEDIATELY EXTINGUISHED, THE PATIENT SUFFERED BURNS IN AND AROUND THE TRACHEOSTOMY SITEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HI-LO TRACHEAL TUBE	N/A	BTR	MALLINCRODT CRITICAL CARE	86113

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Required Intervention