BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEO-SITE BONE BIOPSY NEEDLE

    MDR report key: 9168301 · Received October 8, 2019

    Report

    Report Number
    1820334-2019-02555
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    October 6, 2019
    Report Date
    November 8, 2019
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002123748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT MEDICAL PRODUCTS: PRODUCT RECEIVED ON: 01NOV2019. INVESTIGATION/EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, AND QUALITY CONTROL. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE COMPLAINANT RETURNED THE COMPLAINT DEVICE OPENED BUT UNUSED. VISUAL EXAMINATION SHOWED AN UNKNOWN FIBER WAS FOUND NEAR THE BOTTOM OF THE POUCH. THE BOTTOM SEAL OF THE POUCH WAS THE ONLY SEAL INTACT AND NOT PEELED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. SINCE THERE ARE NO RELATED NONCONFORMANCES OR OTHER COMPLAINTS FROM THIS LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT A MANUFACTURING QUALITY CONTROL DEFICIENCY CONTRIBUTED TO THE DEVICE FAILURE. IT IS POSSIBLE THAT THE QUALITY CONTROL INSPECTION STEP TO CHECK FOR FOREIGN MATTER WAS NOT FULLY PERFORMED. IT IS ALSO POSSIBLE THAT THIS UNKNOWN FIBER ENTERED THE PACKAGING UPON THE USER OPENING THE POUCH, BUT THIS CANNOT BE CONFIRMED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 08OCT2019.

    Additional Manufacturer Narrative · 1

    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 AN OSTEO-SITE BONE BIOPSY NEEDLE WAS INSPECTED PRIOR TO USE. A "CONTAMINANT LIKE A HAIR" WAS OBSERVED INSIDE THE SEALED, PRIMARY PACKAGING. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961398 OSTEO-SITE BONE BIOPSY NEEDLE KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 9853531 00827002123748

    Patients

    Seq Age Sex Outcome Treatment
    1