BEUDAMED
    FDA Adverse Event Injury Summary report: N

    API REAGENT - ZYM B TEST KIT

    MDR report key: 3231408 · Received July 15, 2013

    Report

    Report Number
    3002769706-2013-00003
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 15, 2013
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS INITIATED BY THE BIOMERIEUX MANUFACTURING SITE DUE TO THE REPORTED EVENT. AS PART OF THE INVESTIGATION BIOMERIUX REVIEWED THE PRODUCTION RECORDS / DEVICE HISTORY RECORDS FOR THE REFERENCE LOT AND TESTED RETAINS TO DUPLICATE THE REPORTED ISSUE. THERE WERE NO DEVIATIONS IDENTIFIED IN THE PRODUCTION RECORDS. THE TESTING OF RETAINS INCLUDED PERFORMING THE AMPULE OPENING PROCEDURE AS INDICATED IN THE PACKAGE INSERT ON TEN RETAINED AMPULES BY THREE DIFFERENT TECHNICIANS, AND NO ISSUES WERE ENCOUNTERED. BIOMERIEUX WAS UNABLE TO DUPLICATE THE REPORTED ISSUE AND THE INVESTIGATION DID NOT DETECT A PRODUCT ISSUE WITH ZYM B AMPULES. THIS COMPLAINT IS AN ISOLATED EVENT THAT IS NOT RELATED TO A MALFUNCTION OF THE PRODUCT. THE INSTRUCTIONS ON THE PACKAGE INSERT AND MSDS ARE ADEQUATE AND CORRECTLY INFORMS THE CUSTOMER OF SAFETY PRECAUTIONS TO REDUCE THE POTENTIAL OF AN ADVERSE EVENT. THOUGH THE CUSTOMER WAS NOT INJURED AND HAS EXPERIENCED NO ADVERSE EFFECTS RELATED TO THE EVENT, THIS EVENT IS REPORTABLE AS AN ADVERSE EVENT, BECAUSE MEDICAL INTERVENTION OCCURRED AS A PRECAUTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT SHE WAS OPENING A REAGENT AMPULE OF THE ZYM B TEST KIT (REF. 70493) AND THE GLASS SHATTERED IN HER HANDS. SHE FURTHER STATED THE BROKEN GLASS FROM THE REAGENT AMPULE DID NOT BREAK HER SKIN OR CAUSE ANY BLEEDING. SHE WAS USING THE PROTECTIVE TOP TO SNAP THE AMPULE, BUT WAS NOT USING ANY PERSONAL PROTECTION ON THE BOTTOM (I.E. GLOVES). THIS RESULTED IN ZYM B REAGENT ON HER HANDS AND HER LABORATORY CLOTHING. SHE WAS WEARING SCRUBS AND SAFETY GLASSES, BUT NO GLOVES. THE SPILL WAS CLEANED PER HOSPITAL PROTOCOL. IT WAS NOTED THAT THE CUSTOMER WAS NOT WEARING GLOVES WHEN THE EVENT OCCURRED. AS INDICATED IN THE PACKAGE INSERT WARNINGS/PRECAUTIONS SECTION, "DO NOT ALLOW REAGENT TO COME INTO CONTACT WITH SKIN, EYES OR CLOTHING". THE MATERIAL SAFETY DATA SHEET (MSDS) PROVIDES SPECIFIC INSTRUCTIONS ON HANDLING THIS REAGENT AND FIRST AID MEASURES IF AN ADVERSE EVENT OCCURRED. THE MSDS ALSO PROVIDES DETAILED INFORMATION REGARDING PROTECTIVE GEAR TO WEAR WHEN HANDLING THIS PRODUCT. AFTER REVIEWING THE MSDS FOR THE PRODUCT, THE CUSTOMER WENT TO THE HEALTH AND SAFETY DEPARTMENT, WHICH ASKED HER TO NOTIFY THE MANUFACTURER, AND ADMINISTERED A TETANUS SHOT AS A PRECAUTIONARY MEASURE. NO LABORATORY TESTING WAS PERFORMED. THE CUSTOMER HAS EXPERIENCED NO ADVERSE EFFECTS FROM THE PRODUCT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327794 API REAGENT - ZYM B TEST KIT REAGENT, MICROORGANISM DIFFERENTIATION JTO BIOMERIEUX SA 1001956590

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention