BEUDAMED
    FDA Adverse Event Injury Summary report: N

    21G ECLIPSE NEEDLE

    MDR report key: 1770232 · Received July 22, 2010

    Report

    Report Number
    1024879-2010-00005
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HCW INDICATED THAT THE PT WAS IN A WHEEL CHAIR AND THE (CHAIR) "CUSHION" WAS USED TO CLOSE THE SAFETY CAP. THE SAFE AND CORRECT USE OF THIS PRODUCT IS DEMONSTRATED BY THE IFU WHICH CAN BE FOUND ON THE SHELF CARTON. AFTER A VENIPUNCTURE IS PERFORMED THE USER SHOULD CONTINUE TO HOLD THE ECLIPSE NEEDLE AND HOLDER IN ONE HAND. WITH THE THUMB OF THE SAME HAND, GENTLY PRESS THE SAFETY SHIELD FORWARD USING THE ACTIVATION PAD UNTIL AN AUDIBLE CLICK IS HEARD AND THE SAFETY SHIELD HAS LOCKED IN PLACE. ENGAGING THE SHIELD BY PRESSING OR HITTING ON A HARD OR SOFT SURFACE IS NOT RECOMMENDED AS THIS CAN CAUSE THE SHIELD TO NOT COMPLETELY COVER THE NEEDLE AND OR BECOME DISENGAGED. A COMPLAINT HISTORY CHECK WAS PERFORMED FOR THE IDENTIFIED LOT AND THIS IS THE FIRST (1ST) RECORDED COMPLAINT FOR THIS LOT. SECONDLY, A DEVICE HISTORY REVIEW WAS PERFORMED AND THERE WERE NO DOCUMENTATION CONCERNING ANY QUALITY ISSUES NOTED DURING THE MFG PROCESS. REGULATORY COMPLIANCE WILL CONTINUE TO TRACK AND TREND THE IDENTIFIED LOT AND REPORTED ISSUES. EVAL SUMMARY: CUSTOMER SAMPLES WERE REQUESTED FOR EVAL, BUT NONE HAVE BEEN RECEIVED TO DATE. THIRTY (30) RETENTION SAMPLES WERE EVALUATED FOR DEFECTIVE LOCKING MECHANISM OF THE SHIELD. EACH ONE OF THE SAMPLES WERE HAND ACTIVATED AND THE SHIELDS FOR THE THIRTY (30) DEVICES ALL LOCKED INTO POSITION, COMPLETELY COVERING THE NEEDLE WITHOUT ANY INCIDENCES OF SHIELD BREAKAGE OR SHIELD DISENGAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A BLOOD DRAW ON A PT IN A WHEELCHAIR, THE HEALTH CARE WORKER INDICATED THAT THE "CUSHION" (ON THE CHAIR) WAS USED TO ACTIVATE THE SHIELD ON THE ECLIPSE NEEDLE WHEN IT BROKE. HIS/HER HAND SLIPPED AND THE NEEDLE GRAZED THE THUMB. THIS RESULTED IN A CUT, THE SIZE OF A PAPER CUT. THE CUT WAS CLEANED WITH ALCOHOL AND FORCED TO BLEED. FOLLOW-UP INFO REVEALED THAT BLOOD TESTING WAS DONE ON THE HCW, AND THERE WAS A LOW TITER READING RESULT FOR THE HEPATITIS B BLOOD TEST. AS SUCH A NEW SERIES OF TREATMENT WAS STARTED. NOTE: TREATMENT WAS MOST LIKELY GIVEN AS A PRECAUTION AS THE INFO DID NOT CONFIRM THAT THE HCW TESTED POSITIVE FOR (B)(6). THERE WAS NO CONFIRMATION THAT THE PT (SOURCE) WAS TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 21G ECLIPSE NEEDLE ECLIPSE NEEDLE FMI BD NA 0043485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other