BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE

    MDR report key: 6886321 · Received September 22, 2017

    Report

    Report Number
    2648988-2017-00042
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    August 24, 2017
    Report Date
    September 5, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED ON 12/12/2017. ONE ACCUDRAIN SAMPLE WAS RECEIVED AND IT WAS OBSERVED THAT THE TRANSDUCER WAS CONNECTED TO PATIENT LINE¿S STOPCOCK. UPON CLOSER INSPECTION, IT WAS NOTICED THAT THE PATIENT LINE¿S STOPCOCK WAS CRACKED ON THE SIDE AND BOTTOM. NO LOT NUMBER WAS IDENTIFIED IN THE COMPLAINT BY THE CUSTOMER, BUT A LOT NUMBER WAS OBTAINED FROM THE LABEL OF THE RETURNED SAMPLE RECEIVED. DOCUMENTS AND LOGS REVIEWED FOR LOT 1170060 DID NOT REVEAL ANYTHING THAT COULD CAUSE THE REPORTED EVENTS. NO DEVIATIONS, EVENTS, AND/OR REWORK WERE RECORDED FOR LOT 1170060; THE LOT COMPLIED WITH ALL REQUIREMENTS AS SPECIFIED IN THE RESPECTIVE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. THE ROOT CAUSE FOR THIS EVENT IS UNDETERMINED; NONETHELESS, A PROBABLE CAUSE FOR THIS EVENT COULD BE RELATED TO PRODUCT HANDLING DURING USE. THE BREAKAGE COULD HAVE BEEN CAUSED BY AN UNINTENDED BLOW/HIT, EXCESSIVE FORCE, CHEMICAL SOLVENT EXPOSURE OR ANY OTHER FORTUITOUS EVENT DURING PRODUCT HANDLING OUTSIDE OF INTEGRA¿S CONTROL.

    Description of Event or Problem · 1

    THE EVD WAS CRACKED AND LEAKING CSF AT THE STOPCOCK WHERE THE TRANSDUCER WAS ATTACHED (CRACK IN THE EVD SYSTEM, NOT THE TRANSDUCER). THE SYSTEM WAS CHANGED OUT IMMEDIATELY. IT IS NOT KNOWN WHAT CAUSED THE CRACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667545 ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR 1170060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R