BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALC TOP

    MDR report key: 2608900 · Received June 4, 2012

    Report

    Report Number
    1217183-2012-00009
    Event Type
    Other
    Date Received
    June 4, 2012
    Date of Event
    April 10, 2010
    Report Date
    June 4, 2012
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    JPA
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN AUGUST 2009, A CUSTOMER NOTIFICATION WAS SENT BY OUR DISTRIBUTOR ((B)(4)) TO ALL ACL TOP CUSTOMERS STATING THE PRECAUTIONS THAT SHOULD BE TAKEN WHEN DISPOSING OF REAGENTS, ROUTINE DECONTAMINATION OF DRAINS, AND ALSO DECONTAMINATION OF PLUMBING CONTAINING EXPLOSIVE AZIDES. ALSO INCLUDED WITH THIS NOTIFICATION WERE SUGGESTIONS FOR A WARNING TAG TO BE PLACED ON "YOUR PLUMBING IN A PROMINENT LOCATION" AS A REMINDER OF PROPER DISPOSAL OF REAGENT WASTE. THIS FDA NOTIFIED RECALL ACTION WAS CLOSED WITH 100 PERCENT CUSTOMER NOTIFICATION BY OUR DISTRIBUTOR. FURTHER, ACCORDING TO THE IL MSDS, THE WASTE SOLUTION SHOULD BE SEPARATED FROM ACIDS AND HEAVY METALS BECAUSE OF RISK FOR EXPLOSION. THE KIT HAZARD CLASSIFICATION (EXCERPT): "DO NOT EMPTY INTO DRAINS." SPECIAL REQUIREMENTS: KEEP AWAY FROM ACIDS (SODIUM AZIDE REACTS STRONGLY) AND AWAY FROM CONTAMINATION WITH HEAVY METALS. SODIUM AZIDE HAS BEEN REPORTED TO FORM LEAD OR COPPER AZIDE IN LABORATORY PLUMBING WHICH MAY EXPLODE ON PERCUSSIONS. DO NOT EMPTY INTO DRAINS. BASED ON THE REVIEW AND GOOD LABORATORY PRACTICES, THE PRODUCT LABELING IS CORRECT, WITH NO REMEDIAL ACTION REQUIRED.

    Description of Event or Problem · 1

    THE COMPLAINT CLAIMS THAT AN INDIVIDUAL WAS INJURED WHEN SODIUM AZIDE BUILD UP IN A PIPE HE WAS WORKING ON EXPLODED. AT THE TIME OF THE EXPLOSION, THE SINK WAS BEING REPAIRED AND HAD BEEN OUT OF SERVICE, ALLOWING THE PIPES DRAINING THE SINK TO DRY OUT. THE SINK HAD BEEN USED FOR THE ACL TOP INSTRUMENT. NOTE: EVENT HAPPENED ON APPROXIMATELY (B)(6) 2010 BUT CUSTOMER DID NOT CONTACT OUR DISTRIBUTOR UNTIL APRIL 27, 2012, WHO NOTIFIED (B)(4) ON MAY 04, 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALC TOP COAGULATION INSTRUMENT JPA INSTRUMENTATION LABORATORY ACL TOP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other