BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEO-SITE BONE BIOPSY NEEDLE

    MDR report key: 8780371 · Received July 11, 2019

    Report

    Report Number
    1820334-2019-01667
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 13, 2019
    Report Date
    August 28, 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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

    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 NOT CONSIDERED 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.

    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

    DATE OF EVENT: UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ADHESIA DURO 100 INJECTOR. OCCUPATION: UNKNOWN. INITIAL REPORTER ALSO SENT REPORT TO FDA: UNKNOWN. 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 A OSTEO-SITE BONE BIOPSY NEEDLE WAS DAMAGED DURING THE INJECTION OF BONE CEMENT DURING AN OSTEOPLASTY PROCEDURE. THE DAMAGE OCCURRED "BETWEEN THE BLUE HANDLE AND WHITE TIP WHERE THE CONNECTION IS FIXED." IT IS UNCLEAR THE SPECIFIC DAMAGE TO THE NEEDLE. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574030 OSTEO-SITE BONE BIOPSY NEEDLE KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 8577659 00827002269507

    Patients

    Seq Age Sex Outcome Treatment
    1