FDA Adverse Event Malfunction Summary report: N

FLEX-GUIDE ENDOTRACHEAL TUBE INTRODUCER

MDR report key: 20770860 · Received November 25, 2024

Report

Report Number
20770860
Event Type
Malfunction
Date Received
November 25, 2024
Date of Event
October 19, 2024
Report Date
October 29, 2024
Manufacturer
XPONENT HEALTHCARE INC
Product Code
BSR
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT PRESENTED WITH DISLODGED TRACHEOSTOMY TUBE, STABLE AT TIME OF PRESENTATION. MD ATTEMPTING TO REINSERT NEW TRACHEOSTOMY TUBE 6.0 FR, AND BOUGIE TIP BROKE OFF INTO PATIENT AIRWAY WHEN ATTEMPTING TO REPLACE CURRENT TRACHEOSTOMY WITH NEW TRACH. FIRST AND A SECOND MD WERE PRESENT AT BEDSIDE AT TIME OF PROCEDURE. STORZ FIBER OPTIC SCOPE USED BY MD'S TO VISUALIZE AIRWAY. BOUGIE PLASTIC TUBE SHORTER, WITH CRACKED/JAGGED EDGE UPON INSPECTION. PATIENT MEDICATED WITH ETOMIDATE DURING TRACHEOSTOMY TUBE REPLACEMENT, BAG-VALVE-MASK (BVM) TO SUPPORT BREATHING/OXYGENATION UNTIL MEDICATION WORE OFF. PATIENT ALERT AFTER ETOMIDATE WORE OFF, AIRWAY PATENT, VITAL SIGNS STABLE ON ROOM AIR. REQUIRED TRANSFER TO ANOTHER HOSPITAL FOR RESOURCES NOT AVAILABLE AT CURRENT ED. SIGNIFICANT RESISTANCE MET WHEN USING MODERATE PRESSURE TO RE-INSERT TRACHEOSTOMY TUBE THAT HAD BECOME DISLODGED. INTRODUCER WAS INSERTED FIRST TIME AND ATTEMPT TO RE-INSERT TRACHEOSTOMY WAS MET WITH RESISTANCE. UPON THE SECOND ATTEMPT WITH THE INTRODUCER WAS WHEN THE INTRODUCER SNAPPED. ADDITIONAL INTRODUCERS WERE PULLED FROM STOCK AND FOUND TO ALSO SNAP/CRACK WITH MODERATE PRESSURE. ALL DEVICES WERE PULLED FROM HOSPITAL STOCK AND PATIENT AREAS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2221635 FLEX-GUIDE ENDOTRACHEAL TUBE INTRODUCER STYLET, TRACHEAL TUBE BSR XPONENT HEALTHCARE INC GM85110 111101

Patients

Seq Age Sex Outcome Treatment
1 70 YR Male