BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMO BIOPSY TRAY

    MDR report key: 5056685 · Received September 4, 2015

    Report

    Report Number
    3005011024-2015-00006
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    July 28, 2015
    Report Date
    October 23, 2015
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: (B)(4) WAS RECEIVED INDICATING THAT FINISHED GOOD 89-4073, MAMMO BIOPSY, HAD A NEEDLE THAT CAME OUT OF THE HUB OR BROKE OFF OF THE HUB. THE INFORMATION RECEIVED IDENTIFIED THE ISSUE OCCURRED IN CONNECTION WITH THE 27GA 1 ½ NEEDLE. THE END USER DISCARDED THE ACTUAL PRODUCT, AND THUS, IT WAS UNAVAILABLE FOR EVALUATION. THE ACTUAL PRODUCT WAS DISCARDED BY THE END USER AND UNAVAILABLE FOR EVALUATION. THE INFORMATION RECEIVED WITHIN THE TEXT OF THE COMPLAINT IDENTIFIED THAT THE ISSUE OCCURRED IN CONNECTION WITH THE 27GA 1 ½ NEEDLE. THE (B)(6) REVIEWED OF THE BILL OF MATERIALS (BOM) IN AN EFFORT TO IDENTIFY THE RAW MATERIAL PART NUMBER. (B)(4), WAS IDENTIFIED AND IS SUPPLIED TO DEROYAL BY (B)(4). (B)(4) IS THE RAW MATERIAL SUPPLIER. THE 2013-2015 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR)/ SUPPLIER NOTIFICATION LETTER (SNL) LOGS WERE EVALUATED FOR SIMILAR COMPLAINTS. NO SIMILAR COMPLAINTS WERE IDENTIFIED, BUT DUE TO THE NATURE OF THE REPORT, SCAR2015-268KJG WAS ISSUED. SCAR2015-268KJG WAS DUE ON (B)(6)2015. THE (B)(6) HAS BEEN IN COMMUNICATION WITH CONTACTED (B)(4) IN REFERENCE TO THE SCAR RESPONSE ON THE FOLLOWING DATES: (B)(6) 2015. THE DEROYAL SUPPLY CHAIN DEPARTMENT HAS BEEN WAS INCLUDED IN THE COMMUNICATION WITH THE VENDOR FOR AWARENESS OF THE REPORT AND THE SCAR RESPONSE NOT BEING RETURNED TO DEROYAL BY THE DUE DATE. (B)(4) RESPONDED VIA EMAIL, ON (B)(6) 2015, DETAILING THE SCAR RESPONSE WILL NOT BE PROVIDED WITHIN THE 15 DAY CRITERIA SET BY DEROYAL. REFER TO THE (B)(4) EMAIL COMMUNICATION ATTACHMENT. THE QC COMPLAINT SPECIALIST DECIDED TO FORWARD THE COMPLAINT FOR CLOSURE AND RE-OPEN ONCE THE SCAR RESPONSE IS RECEIVED. THE OUTSTANDING SCAR WILL BE MONITORED THROUGH THE 2015 SCAR LOG. CORRECTION: A CREDIT HAS BEEN PROVIDED. ROOT CAUSE ANALYSIS: THE REPORTED ISSUE HAS BEEN DETERMINED TO BE AN ISOLATED REPORT DUE TO AN UNDETERMINED ROOT CAUSE. THE TRUE ROOT CAUSE IS UNABLE TO BE DETERMINED DUE TO A LACK OF SAMPLE FOR EVALUATION AND THE OUTSTANDING SCAR RESPONSE NOT BEING PROVIDED BY (B)(4). CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. THIS REPORT WILL BE UPDATED AS MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: (B)(4) SUPPLIED THE RAW MATERIAL (PART NUMBER 4-2894) TO DEROYAL. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO (B)(4) AND RESPONSE RECEIVED ON 9/28/2015. IN ITS RESPONSE, (B)(4) CONCLUDED THAT BECAUSE A LOT NUMBER WAS NOT PROVIDED AND A SAMPLE UNAVAILABLE FOR EVALUATION, A ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED TO DETERMINE A ROOT CAUSE ANALYSIS FOR THE REPORTED ISSUE. A POSSIBLE ROOT CAUSE COULD BE THE METHOD OF INJECTION. BENDING OF THE CANNULA, WHILE INSERTED ALL THE WAY TO THE HUB, MAY CAUSE THE REPORTED ISSUE. PRIOR TO A LOT'S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, SAMPLES FROM ALL NEEDLE LOTS ARE TESTED FOR CANNULA TO HUB PULL FORCES. CORRECTIVE ACTION: (B)(4)STATED IN ITS SCAR RESPONSE THAT CORRECTIVE ACTION IS NOT NECESSARY AT THIS TIME. THE INFORMATION WILL BE USED FOR TRACKING AND TRENDING TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS. DEROYAL WILL CONTINUE TO MONITOR TRENDS FOR THIS FAILURE AND WILL RECOGNIZE IN THE FUTURE IF IT TRANSITIONS INTO A RECURRING ISSUE. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED. SUSPECT DEVICE THROWN AWAY.

    Description of Event or Problem · 1

    WHEN THE RADIOLOGIST WAS REMOVING THE NEEDLE USED FOR DEEP NUMBING OF THE BREAST FOR BIOPSY, THE NEEDLE CAME OUT OF THE HUB OR BROKE OFF OF THE HUB. COULD NOT EXAMINE IT AS IT WENT RIGHT INTO THE SHARPS.

    Description of Event or Problem · 1

    WHEN THE RADIOLOGIST WAS REMOVING THE NEEDLE USED FOR DEEP NUMBING OF THE BREAST FOR BIOPSY, THE NEEDLE CAME OUT OF THE HUB OR BROKE OFF OF THE HUB. COULD NOT EXAMINE IT AS IT WENT RIGHT INTO THE SHARPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587448 MAMMO BIOPSY TRAY KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1