BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 17639183 · Received August 29, 2023

    Report

    Report Number
    3002808486-2023-00227
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    July 21, 2023
    Report Date
    October 26, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    UDI-DI
    00827002483033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K161813. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BLUE PLASTIC CAME OFF THE FROVA DEVICE WHILE INTUBATING WITH AN UNKNOWN SINGLE LUMEN TUBE. NO UNINTENDED PART OF DEVICE REMAINED INSIDE THE PATIENT AND NO ADVERSE EFFECT OF THE PATIENT WAS REPORTED. THE FROVA INTRODUCER WAS RETURNED AND SO WERE TWO SMALL FRAGMENTS OF THE BLUE INTRODUCER MATERIAL. THE INTRODUCER APPEARED UNUSED, BUT TWO SHAVINGS WERE NOTED AND SOME MATERIAL, LIKELY GEL, WAS FOUND IN THE SIDE-HOLE. BASED ON THESE FINDINGS THE EXACT REASON FOR THE FROVA MATERIAL TO COME OFF DURING INTUBATION CANNOT BE DETERMINED. BUT CONSIDERING THE INNER DIAMETER OF THE ENDOTRACHEAL TUBE IS UNKNOWN AND THE FACT THAT REPORTEDLY THE FROVA INTRODUCER NOR THE ENDOTRACHEAL TUBE WAS LUBRICATED PRIOR TO USE THE DIFFICULTIES ARE CONSIDERED OF NO FAULT TO THE FROVA INTRODUCER. ACCORDING TO THE INSTRUCTIONS FOR USE THE FROVA INTRODUCER IT IS DESIGNED FOR PLACEMENT OF A SINGLE LUMEN ENDOTRACHEAL TUBE WHOSE INNER DIAMETER IS 6MM OR LARGER. FURTHERMORE, THE IFU ALSO WARN AND INSTRUCT TO LUBRICATE THE CATHETER INTRODUCER AND THE ENDOTRACHEAL TUBE BEFORE USE AND THAT CARE MUST BE TAKEN WHEN INTRODUCING/REMOVING THE CATHETER INTRODUCER FROM THE ENDOTRACHEAL TUBE, AS CONTACT WITH SHARP EDGES ON THE INTERNAL SURFACE OF THE ENDOTRACHEAL TUBE MAY CAUSE SMALL FRAGMENTS TO BE SHAVED OFF THE INTRODUCER. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED, 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 21CFR 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: BLUE PLASTIC CAME OFF THE FROVA BOUGIE WHILE INTUBATING. PATIENT OUTCOME: NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. 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
    1057614 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE E4407939 00827002483033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention