BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 8960330 · Received September 4, 2019

    Report

    Report Number
    1820334-2019-02216
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Report Date
    October 23, 2019
    Manufacturer
    COOK INC
    Product Code
    BWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. A REVIEW OF DOCUMENTATION AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD FOUND THAT PROPER PROCEDURES ARE IN PLACE TO IDENTIFY AND PREVENT THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF THE PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE WAS NOT ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

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

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: RPN AND PRODUCT INFORMATION CURRENTLY UNAVAILABLE. COMMON DEVICE NAME / PROCODE: 2 PROCODES LISTED FOR MELKER EMERGENCY CRICOTHYROTOMY CATHETER: BWC NEEDLE, EMERGENCY AIRWAY AND JOH TUBE TRACHEOSTOMY AND TUBE CUFF. PMA/510(K) #: THE RPN FOR THIS DEVICE IS UNKNOWN, THEREFORE THERE ARE TWO POSSIBLE 501K CODES: K013196 AND K010016. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN HAD AN ISSUE WITH A MELKER EMERGENCY CRICOTHYROTOMY CATHETER KIT. THE PHYSICIAN COULDN'T CONFIRM IF IT WAS A COOK PRODUCT, BUT SAID THE COMPLAINT DEVICE LOOKED SIMILAR. THE PHYSICIAN NOTED THAT IS WAS "HARD TO INSERT DUE TO THE ¿LIP¿ ON THE CATHETER". THE EXACT DATE OF EVENT COULD NOT BE PROVIDED, HOWEVER, IT OCCURRED APPROXIMATELY A FEW MONTHS BEFORE THE DATE REPORTED ON 21 AUG 2019. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757227 UNKNOWN UNKNOWN BWC COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1