BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 9353343 · Received November 21, 2019

    Report

    Report Number
    3002808486-2019-01847
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Report Date
    November 22, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    UDI-DI
    00827002483033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE UNDER PMA/510(K) K161813. SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON EVENT DESCRIPTION AND THE UNUSED DEVICE RETURNED UNDER (B)(4). IT WAS REPORTED THAT THE STYLET DOES NOT MEET THE DEMANDS OF A DIFFICULT INTUBATION; SEMI RIGID, ANTERIOR ARTICULATION, AND TOO FLEXIBLE AND MALLEABLE. THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED, BUT AN UNOPENED AND UNUSED DEVICE FROM THE SAME LOT WAS RETURNED UNDER (B)(4) AND AN INVESTIGATION OF THE RETURNED DEVICE REVEALED A SMOOTH SURFACE AND NO SIGNS OF DEGRADATION OR ANY MATERIAL DEFECTS. THEREFORE, IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE FROVA DEVICE TO BECOME SEMI RIGID AND TOO FLEXIBLE AND MALLEABLE AS REPORTED. IT IS NOTED THAT THE FROVA DEVICE WAS REPORTEDLY "STORED IN THE OPERATING THEATRE WITH AIR CONDITIONING", BUT ALSO THAT THE "BOUGIE SUFFERED WITH THE CANICULE". ACCORDING TO THE INSTRUCTIONS FOR USE THE DEVICE MUST BE STORED IN A DARK, DRY, COOL PLACE. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS STYLET DOES NOT MEET THE DEMANDS OF A DIFFICULT INTUBATION, SEMI RIGID, ANTERIOR ARTICULATION, TOO FLEXIBLE AND MALLEABLE. THE BOUGIE DOESN'T MEET THE REQUIREMENTS OF A DIFFICULT INTUBATION. SEMI STIFFNESS, ANTERIOR BENDING, TOO SOFT AND MALLEABLE. VITAL RISK IN CASE OF DIFFICULT AIRWAY INTUBATION. THE BOUGIE CROUCHES IN THE OTHER DIRECTION AS IT TOUCHES AN OBSTACLE. IF YOU COULDN'T INTUBATE , YOU HAVE A RISK OF DEATH OF THE PATIENT, YOU HAVE TO USE OTHER DEVICE TO HELP YOU: VIDEOLARYNGOSCOPY, FASTRACK, MELKER CRICOTHYROTOMIES SET ¿IT HAPPENED TWICE¿. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147722 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE G48303 E3848458 00827002483033

    Patients

    Seq Age Sex Outcome Treatment
    1