BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSATREK REDOX 1 EZ DRAW 40ML W/STIR BAR

    MDR report key: 2508663 · Received March 26, 2012

    Report

    Report Number
    2183729-2012-00001
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS
    Product Code
    MDB
    PMA / PMN Number
    921637/A
    Removal / Correction Number
    PENDING
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER FILED COMPLAINT WITH TREK (MFGR): CUSTOMER IDENTIFIED NON-VIABLE GRAM-POSITIVE COCCI (NVGPC) IN CHAINS FOLLOWING GRAM-STAINING OF A BOTTLE THAT SIGNALED POSITIVE. MANUFACTURER INVESTIGATION PERFORMED ON RETENTION UNITS OF SAME PRODUCT LOT AND CONFIRMED PRESENCE OF NVGPC IN CHAINS IN SOME PARTS OF THE LOT AT LEVELS EXCEEDING PRODUCT RELEASE SPECIFICATIONS. RETENTION UNITS OF LOTS PRODUCED IMMEDIATELY PRECEDING AND FOLLOWING THE REPORTED LOT WERE ALSO EXAMINED AND FOUND TO BE WITHIN SPECIFICATIONS WITH THE EXCEPTION OF PRODUCT 7101-44 REDOX 2 40ML, LOT 154778SA MANUFACTURED ON 12/22/2011 (THE FIRST LOT MANUFACTURED FOLLOWING THE REPORTED REDOX 1 LOT) WHICH ALSO EXHIBITED PRESENCE OF NON-VIABLE ORGANISMS IN SOME PARTS OF THE LOT AT LEVELS EXCEEDING PRODUCT RELEASE SPECIFICATIONS. THE SAME 3 REACTORS WERE USED TO PRODUCE BOTH LOTS AND OUT OF SPECIFICATIONS RESULTS WERE OBTAINED IN REACTOR 3 FOR THE REDOX 1 LOT AND IN REACTOR 1 AND 3 FOR THE REDOX 2 LOT. REMAINING INVENTORY OF THE REDOX 1 LOT WAS QUARANTINED; ALL UNITS OF THE REDOX 2 LOT HAD ALREADY BEEN DISTRIBUTED. PRODUCT HAS BEEN REPLACED FOR CUSTOMER. A CORRECTION RECALL WILL BE INITIATED TO NOTIFY ALL CUSTOMERS. WHILE NO SPECIFIC CAUSE COULD BE IDENTIFIED, PROBABLE CAUSE IS CONSIDERED TO BE RELATED TO EITHER FILTER INSTALLATION OR BIOBURDEN BUILD-UP IN HOSES AND/OR CARBOY. PREVENTIVE MEASURES TO BE IMPLEMENTED INCLUDE REVISION OF CLEANING PROCESS BETWEEN USE OF EACH REACTOR AND REPLACEMENT OF HOSES, FILTER HOUSING/SPRINGS, CARBOY INCLUDING FILTER AND UPTAKE WANDS, AND ADDITIONAL SAMPLING AS PART OF PRODUCT RELEASE TESTING.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSATREK REDOX 1 EZ DRAW 40ML W/STIR BAR MDB TREK DIAGNOSTIC SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1