BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL ELITE

    MDR report key: 3535231 · Received December 13, 2013

    Report

    Report Number
    1217183-2013-00016
    Event Type
    Injury
    Date Received
    December 13, 2013
    Date of Event
    November 15, 2013
    Report Date
    November 15, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    JPA
    PMA / PMN Number
    K060162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LABORATORY CO. HAS TAKEN THE FOLLOWING ACTIONS OVER THE YEARS TO MITIGATE THE RICK OF SODIUM AZIDE EXPLOSIONS: OUR PRODUCT LABELING IDENTIFIES REAGENTS THAT CONTAIN (B)(4). WE ADVICE IN THE MSDS FOR THESE PRODUCTS THAT THE WASTE SOLUTION SHOULD BE SEPARATED FROM ACIDS AND HEAVY METALS DUE TO EXPLOSION RISK. IN 2009, AN URGENT SAFETY NOTIFICATION WAS ISSUED (UNDER THE DIRECTION OF THE FDA), WARNING ALL IL INSTRUMENT USERS OF THE HAZARDS OF SODIUM AZIDE IN THE INSTRUMENT WASTE. THE LETTER ADVISES OUR CUSTOMERS TO TAKE PRECAUTIONS WHEN DISPOSING OF REAGENTS, ROUTINE DECONTAMINATION OF DRAINS AND ALSO DECONTAMINATION OF PLUMING CONTAINING (B)(4). THE LETTER ALSO CONTAINS A "WARNING" STATING THE DECONTAMINATION OF THE PLUMBING SYSTEM DOES REDUCE THE RISK OF AN EXPLOSION. HOWEVER, A DECONTAMINATED SYSTEM SHOULD STILL BE TREATED WITH CAUTION, AND MAINTENANCE PEOPLE SHOULD BE ALERTED SO THE PROPER PRECAUTIONS CAN BE TAKEN. IN OCTOBER OF 2013 INSTRUMENTATION LABORATORY SENT OUT AN URGENT SAFETY NOTIFICATION AS A REMINDER TO OUR CUSTOMERS THAT THE WASTE FROM THEIR IL HEMOSTASIS SYSTEMS CONTAIN (B)(4) THAT MAY POTENTIALLY FORM EXPLOSIVES IN METAL PLUMBING. THIS NOTIFICATION INCLUDED A LETTER WITH WORKAROUND INSTRUCTIONS AND EMPHASIZED THAT GOOD LABORATORY PRACTICES SHOULD BE USED TO MITIGATE THE RISK OF EXPLOSION. (B)(6) ACKNOWLEDGED RECEIPT AND RETURN OF THE 2013 URGENT SAFETY NOTIFICATION RESPONSE TRACKING FORM. THEREFORE, NO REMEDIAL ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A MAINTENANCE WORKER AT THEIR FACILITY HAD REMOVED A PIECE OF PLUMBING FROM THEIR SINK IN THE LAB. WHEN THE MAINTENANCE WORKER ATTEMPTED TO MOVE THE PIECE OF PIPE ON A COUNTER, THE PIECE OF PIPE EXPLODED. THE MAINTENANCE WORKER SUSTAINED AN INJURY TO HIS LEFT HAND, WITH METAL SHARDS BECOMING EMBEDDED IN HIS FLESH. SURGERY WAS REQUIRED AT THE TIME OF THE EXPLOSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653008 ACL ELITE NI JPA INSTRUMENTATION LABORATORY (IL) CO. 8803-11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other