BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEO-SITE BONE BIOPSY NEEDLE

    MDR report key: 8703604 · Received June 17, 2019

    Report

    Report Number
    1820334-2019-01461
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 4, 2019
    Report Date
    August 22, 2019
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002137622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. COMMON DEVICE NAME AND PROCODE: KNW - INSTRUMENT, BIOPSY. 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 FOR A VERTEBROPLASTY. AS REPORTED, "BIOPSY NEEDLE CAP BROKE INNER NEEDLE WHILE IN PATIENT. WAS REMOVED AND QUICKLY REPLACE WITH ANOTHER. PROCEDURE CONTINUED WITHOUT INCIDENT. NO HARM TO PATIENT. NO ADDITIONAL PROCEDURES NEEDED." IT WAS FURTHER REPORTED, "THE DEVICE APPEARED TO HAVE BROKEN THE BLUE CAP OFF (SIC)." AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499459 OSTEO-SITE BONE BIOPSY NEEDLE KNW COOK INC N/A 8701541 00827002137622

    Patients

    Seq Age Sex Outcome Treatment
    1