BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEO-SITE BONE BIOPSY NEEDLE

    MDR report key: 8803783 · Received July 18, 2019

    Report

    Report Number
    1820334-2019-01729
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    August 22, 2019
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002269507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS EVENT IS NOT REPORTABLE. UPON FURTHER INVESTIGATION, THIS EVENT IS NOT REPORTABLE. A REVIEW OF REPORTING SOFTWARE FOR SIMILAR EVENTS (LUER LOCK SEPARATION/DAMAGE AT THE HUB) DOES NOT INDICATE A PREVIOUS INCIDENT OF PATIENT HARM FROM THE COMPLAINT DEVICE OR SIMILAR DEVICES. A REVIEW OF RISK DOCUMENTATION DOES NOT INDICATE THAT THIS EVENT IS LIKELY TO CAUSE SERIOUS INJURY IF IT WERE TO REOCCUR. AS THERE ARE NO RECORDED INCIDENCES OF SERIOUS INJURY DUE TO THE COMPLAINT EVENT, AND IT IS NOT LIKELY THAT SERIOUS INJURY WOULD RESULT IF THE EVENT WERE TO RECUR, PER 21CFR PART 803.50 THE COMPLAINT EVENT IS CONSIDERED NOT REPORTABLE.

    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.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: UNKNOWN. OCCUPATION: UNKNOWN. REPORT SOURCE: OTHER: COUNTRY OF ORIGIN: (B)(6). PMA/510(K) #: K170008. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN OSTEO-SITE BONE BIOPSY NEEDLE WAS USED IN AN UNKNOWN PATIENT DURING AN UNKNOWN PROCEDURE. THE OPERATOR REPORTED ¿AFTER THE INTRODUCTION OF THE DEVICE AND WHEN CONNECTING THE WHITE PART IT BREAKS, MAKING THE DEVICE UNUSABLE.¿ THE DEVICE WAS RECOVERED AND DISCARDED. INFORMATION REGARDING THE PATIENT OUTCOME IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596174 OSTEO-SITE BONE BIOPSY NEEDLE KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 8577646 00827002269507

    Patients

    Seq Age Sex Outcome Treatment
    1