BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD FACS SAMPLE PREP ASSISTANT I

    MDR report key: 1172710 · Received September 12, 2008

    Report

    Report Number
    2916837-2008-00007
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    TECAN US INC.
    Product Code
    GKZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BD BIOSCIENCES WILL SEND A CUSTOMER LETTER AND USER BULLETIN IN THE FIELD CORRECTIVE ACTION KIT TO ALL BD FACS SAMPLE PREP I CUSTOMERS ADVISING THEM TO FOLLOW THE NEW PROBE REPLACEMENT PROCESS WHEN CHANGING THE PROBE AS A PART OF THEIR PREVENTATIVE MAINTENANCE PROGRAM. AN INTERNAL SERVICE BULLETIN WILL ALSO BE SENT TO ALL BD BIOSCIENCES FIELD SERVICE ENGINEERS ADVISING THEM TO FOLLOW THE NEW PROCESS WHEN CHANGING THE SPA PROBE TO REDUCE THE RISK.

    Description of Event or Problem · 1

    A BD FIELD SERVICE ENGINEER WAS CONDUCTING A PREVENTATIVE MAINTENANCE PROCEDURE ON THE BD SAMPLE PREP ASSISTANT I. HE WAS FOLLOWING RECOMMENDED SAFETY PRECAUTIONS WEARING GLOVES AND A SMOCK. THE INSTRUMENT HAD GONE THROUGH A CLEANING PROCEDURE USING BD FACSCLEAN WHICH CONTAINS 10% BLEACH 2 HOURS PRIOR. THE CUSTOMER ASKED HIM TO REPLACE THE PROBE. HE FOLLOWED THE PROBE REPLACEMENT PROCEDURE BY LOOSENING THE SET SCREW. HE ENCOUNTERED SOME DIFFICULTY REMOVING THE PROBE WITH THE PLASTIC CASE ENCAPSULATING THE PROBE NEEDLE WHICH WAS SLIPPING OFF. HE THEN REMOVED THE PLASTIC CASING AND CONTINUED USING PLIERS TO PULL THE PROBE. WITH THE PLIERS HE PULLED THE PROBE STRAIGHT DOWN WITH HIS RIGHT HAND WHILE HOLDING THE SHAFT STEADY WITH HIS LEFT. DUE TO THE REQUIRED FORCE TO BREAK THE PROBE LOOSE, THE TIP OF THE PROBE HIT THE BOTTOM OF THE UNIT CAUSING THE BACK END OF THE BLUNT PROBE TO BOUNCE UP AND STRIKE HIS LEFT THUMB. A NEEDLE STICK OCCURRED WHICH RESULTED IN A SMALL PUNCTURE AND THE ENGINEER NOTICED A SMALL DROP OF HIS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD FACS SAMPLE PREP ASSISTANT I SPA I GKZ TECAN US INC. 334080 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other