BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEO-SITE BONE BIOPSY NEEDLE

    MDR report key: 8792812 · Received July 16, 2019

    Report

    Report Number
    1820334-2019-01692
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    April 16, 2019
    Report Date
    August 22, 2019
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002130197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE COMPLAINANT DID PROVIDE PHOTOS OF THE DEVICE, CONFIRMING THE FAILURE MODE. THE INVESTIGATION FOUND THAT THE AFFECTED COMPONENT IS SUPPLIED TO COOK FROM AN EXTERNAL SUPPLIER. THE SUPPLIER HAS TAKEN THE APPROPRIATE ACTION TO ADDRESS THIS COMPONENT FAILURE. ADDITIONALLY, COOK COMPLETED A REVIEW OF THE DEVICE HISTORY RECORD OF THE LOT AND SIMILAR DEVICE LOTS AND FOUND NO RELEVANT NON-CONFORMANCES. COOK CONDUCTED A REVIEW OF COMPLAINTS FROM THE SAME LOTS AND FOUND NO OTHER REPORTED COMPLAINTS ASSOCIATED WITH THE LOTS. HOWEVER, ADDITIONAL NON-CONFORMING PRODUCT IS SUSPECTED DUE THE TREND OF COMPLAINTS AND SUPPLIER INVESTIGATION RESULTS. ACTION HAS BEEN TAKEN TO PREVENT ADDITIONAL PRODUCT DISTRIBUTION. THE RISK ASSOCIATED WITH THE LUER LOCK CONNECTOR WAS REVIEWED AND DETERMINED TO BE LOW. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED THAT THE ROOT CAUSE IS ¿MANUFACTURING DEFICIENCY ¿ SUPPLIER¿ AND ¿QUALITY CONTROL DEFICIENCY ¿ SUPPLIER. APPROPRIATE MEASURES HAVE BEEN TAKEN TO ADDRESS THIS FAILURE MODE. 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.

    Additional Manufacturer Narrative · 0

    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.

    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

    OCCUPATION: QUALITY ENGINEER. INITIAL REPORTER ALSO SENT REPORT TO FDA: UNKNOWN. PMA/510(K) #: K170008. DEVICE AVAILABLE FOR EVALUATION: UNKNOWN. 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 ON AN UNKNOWN PATIENT DURING AN UNKNOWN PROCEDURE. AS REPORTED, ¿THERE IS A PIECE OF THE END OF THE NEEDLE IN THE LEUR-LOCK END OF THE SYRINGE. IT SNAPPED OFF RIGHT AT THE SYRINGE WHERE IT WAS ATTACHED IN THE "U" SPACE OF THE BLUE HANDLE AREA.¿ THE REST OF THE NEEDLE WAS THEN REMOVED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587758 OSTEO-SITE BONE BIOPSY NEEDLE KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 8577639 00827002130197

    Patients

    Seq Age Sex Outcome Treatment
    1