BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    150 ML W/ FILL TUBE LF 6000

    MDR report key: 9545376 · Received January 3, 2020

    Report

    Report Number
    1060680-2019-00013
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 6, 2019
    Report Date
    February 5, 2020
    Manufacturer
    COEUR, INC.
    Product Code
    DXT
    UDI-DI
    00749756319799
    PMA / PMN Number
    K960965
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE SYRINGE IS SUPPLIED TO DEROYAL BY COEUR, INC. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO COEUR AS WELL AS THE RETURNED SAMPLES. IN ITS SCAR RESPONSE, COEUR STATED IT WAS UNABLE TO DUPLICATE THE FAILURE AT 1,200 PSI, WHICH IS WITHIN SPECIFICATION. ONLY WHEN THE PRESSURE WAS INCREASED TO BEYOND SPECIFICATION WAS FAILURE OBSERVED. SPECIFICALLY, THE AVERAGE PRESSURE AT FAILURE WAS 2,299 PSI. THE FOLLOWING ARE POTENTIAL ROOT CAUSES AS IDENTIFIED BY COEUR: WEAR OF THE PRESSURE JACKET INSTALLED ON THE INJECTOR, WHICH MAY ALLOW THE SYRINGE TO SWELL AND THE PLUNGER TO LOOSEN; SYRINGE NOT ADEQUATELY CONNECTED TO THE PLUNGER, ALLOWING IT TO SEPARATE DURING USE; AND WEAR OF THE INJECTOR COMPONENTS THAT ENGAGE THE PLUNGER. CORRECTIVE ACTION: IN ITS RESPONSE, COEUR, INC. STATED THE INJECTOR EQUIPMENT, INCLUDING THE PRESSURE JACKET AND RAM TIP COMPONENTS, SHOULD BE REVIEWED FOR SERVICING. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING AN INJECTOR SYRINGE (PART 77-150269, LOT IAT001905) MALFUNCTIONED DURING USE. SPECIFICALLY, THE PLUNGER POPPED OUT. THE SAMPLES WERE RECEIVED DECEMBER 17, 2019 AND ENCLOSED WITHIN BIOHAZARD BAGS. THESE SAMPLES WERE EVALUATED, AND ON MOST OF THE RETURNED PRODUCT, THE PLUNGERS WERE INSIDE OF THE TUBES. ONE SAMPLE DID NOT HAVE A PLUNGER, AND ANOTHER SAMPLE HAD CONTRAST IN THE TUBE WITH THE PLUNGER INTACT. STOCK ON-HAND WAS CHECKED AND FOUND TO BE ACCEPTABLE. TWENTY EACH WERE OPENED AND ALL PLUNGERS WERE INTACT. EACH PLUNGER WAS PUSHED INTO THE SYRINGE AND REMAINED INTACT. AFTER THE PLUNGER WAS PUSHED INTO THE TUBE, EACH SYRINGE WAS SET IN AN UPRIGHT POSITION AND NO PLUNGERS FELL OUT. THE WORK ORDER WAS REVIEWED AND SHOWED NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT REQUIRES THE END USER UTILIZE WITH AN ADAPTOR AND JACKET. THE PRODUCT MARKETING REPRESENTATIVE CONFIRMED WITH THE END USER THAT THEY WERE USING THE DEROYAL-SUPPLIED ADAPTOR AND JACKET WITH THE AFFECTED DEVICE. THE PRODUCT IS COMPLETE WHEN IT ARRIVES TO DEROYAL. THE SUPPLIER, COEUR, INC., IS THE FINISHED DEVICE MANUFACTURER. DEROYAL RELABELS AND STERILIZES THE PRODUCT. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO COEUR. A RESPONSE WAS RECEIVED AND ACCEPTED JANUARY 29, 2020 BY DEROYAL PERSONNEL. A TOTAL OF (B)(4) UNITS HAVE BEEN SOLD FROM JANUARY 2017 TO PRESENT WITH A SALES-TO-COMPLAINTS RATIO OF (B)(4). THERE HAVE BEEN FOUR COMPLAINTS DURING THIS TIME FRAME WITH ONE BEING IDENTIFIED AS A LIKE COMPLAINT. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    THE SYRINGE PLUNGER POPPED OUT DURING AN ANGIOGRAM PROCEDURE. THE CLINICIAN HAD TO STOP THE CASE AND RELOAD THE INJECTOR.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING AN INJECTOR SYRINGE (PART 77-150269, LOT IAT001905) MALFUNCTIONED DURING USE. SPECIFICALLY, THE PLUNGER POPPED OUT. THE SAMPLES WERE RECEIVED DECEMBER 17, 2019 AND ENCLOSED WITHIN BIOHAZARD BAGS. THESE SAMPLES WERE EVALUATED, AND ON MOST OF THE RETURNED PRODUCT, THE PLUNGERS WERE INSIDE OF THE TUBES. ONE SAMPLE DID NOT HAVE A PLUNGER, AND ANOTHER SAMPLE HAD CONTRAST IN THE TUBE WITH THE PLUNGER INTACT. STOCK ON-HAND WAS CHECKED AND FOUND TO BE ACCEPTABLE. TWENTY EACH WERE OPENED AND ALL PLUNGERS WERE INTACT. EACH PLUNGER WAS PUSHED INTO THE SYRINGE AND REMAINED INTACT. AFTER THE PLUNGER WAS PUSHED INTO THE TUBE, EACH SYRINGE WAS SET IN AN UPRIGHT POSITION AND NO PLUNGERS FELL OUT. THE WORK ORDER WAS REVIEWED AND SHOWED NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT REQUIRES THE END USER UTILIZE WITH AN ADAPTOR AND JACKET. THE PRODUCT MARKETING REPRESENTATIVE CONFIRMED WITH THE END USER THAT THEY WERE USING THE DEROYAL-SUPPLIED ADAPTOR AND JACKET WITH THE AFFECTED DEVICE. THE PRODUCT IS COMPLETE WHEN IT ARRIVES TO DEROYAL. THE SUPPLIER, (B)(4), IS THE FINISHED DEVICE MANUFACTURER. DEROYAL RELABELS AND STERILIZES THE PRODUCT. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4). AT THE TIME OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. THIS REPORT WILL BE UPDATED WHEN NEW AND CRITICAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE SYRINGE PLUNGER POPPED OUT DURING AN ANGIOGRAM PROCEDURE. THE CLINICIAN HAD TO STOP THE CASE AND RELOAD THE INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12058 150 ML W/ FILL TUBE LF 6000 INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT COEUR, INC. 77-150269 IAT001905 00749756319799

    Patients

    Seq Age Sex Outcome Treatment
    1