BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 14237264 · Received April 28, 2022

    Report

    Report Number
    3002808486-2022-00282
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 31, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    UDI-DI
    10827002236469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE UNDER PMA/510(K) K161813. INVESTIGATION IS STILL IN PROGRESS

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE FROVA INTUBATING INTRODUCER FRACTURED WHEN ADVANCING IT THROUGH THE TRACHEA. HOWEVER, A SINGLE TUBE WAS ADVANCED AND THE FRACTURED FROVA WAS CAREFULLY REMOVED. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE. NO DEVICE WAS RETURNED FOR ANALYSIS, BUT PHOTOS PROVIDED SHOWED THE FROVA INTRODUCER PLACED ON THE BACK OF A WHITE TYVEK POUCH. THE FROVA DEVICE AS WELL AS POUCH WERE VERY CLEAN, IE THE DEVICE APPEARED UNUSED. THE TIP OF THE FROVA HAD PARTIALLY SNAPPED APPROX. 10CM FROM THE MOST DISTAL TIP, IE IN THE AREA AT THE END OF THE STYLET INSIDE. BASED ON THE PHOTOS AND THE INFORMATION PROVIDED THE EXACT REASON FOR THE DEVICE TO SNAP CANNOT BE DETERMINED, BUT THE INTRODUCER MAY HAVE BEEN PUSHED/FORCED TOO HARD AGAINST THE BLADE OF THE LARYNGOSCOPE AS PASSED THROUGH THE AIRWAY AND EXTENDED PAST THE END OF THE BLADE AND THE FORCE USED MAY HAVE CAUSED THE FROVA INTRODUCER TO SNAP AT THE END OF THE STYLET. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FROVA INTUBATING INTRODUCER FRACTURED APPROXIMATELY AT THE 10CM MARKING WHILE INTUBATING THE PATIENT. LUBED UP THE BOUGIE AND USED A GLIDESCOPE TO GUIDE IT TO THE AIRWAY. AS THEY WENT TO GO THROUGH THE TRACHEA THE BOUGIE SPLIT, NEEDING TO INTUBATE QUICKLY THEY PROCEEDED TO SLOWLY GUIDE THE TUBE OVER THE BOUGIE AND WITHDRAW IT AS CAREFULLY AS THEY COULD. THEY FEEL THAT THE AMOUNT OF LUBE ON THE BOUGIE PREVENTED ANY UNNECESSARY FRICTION TO CAUSE FURTHER BREAKAGE. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190045 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE E3998051 10827002236469

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female