BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAMPOLE LABORATORIES

    MDR report key: 30995 · Received February 2, 1996

    Report

    Report Number
    30995
    Event Type
    Injury
    Date Received
    February 2, 1996
    Date of Event
    April 20, 1995
    Report Date
    May 2, 1995
    Manufacturer
    WAMPOLE LABORATORIES DIV, CASTER-WALLACE, INC.
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHLEBOTOMIST WAS DRAWING BLOOD FROM HIV PT. UPON FINISHING BLOODCULTURES, SHE BEGAN ISOLATOR TUBES FOR AFB. SHE FILLED FIRST ISOLATOR AND THEN TOOK SECOND ISOLATOR TO FILL IT BUT ENCOUNTERED DIFFICULTY. AS A RESULT SHE USED A 10 CC SYRINGE AND NEEDLE TO SPARE THE PT ANOTHER STICK.THE PHLEBOTOMIST UPON DRAWING THE BLOOD, SUBSEQUENTLY INSERTED THE NEEDLE INTO THE STOPPER OF THE ISOLATOR TUBE. SHE PICKED THE TUBE UP WITH HER RIGHT HAND AND TAPPED THE PLUNGER OF THE SYRINGE WITH HER LEFT THUMB TO GET IT STAERTED. AND SHE DID THIS, THE TUBE EXPLODED SENDING A PRESSURIZED MISTY SPRAY OF BLOOD INTO HER FACEAND EYES. THE TUBE AND SYRINGE WERE PLACED IN THE BIOHAZARD BUCKET ON THE WALL OF THE PT'S ROOM. THE BOX WAS LATER IMPOUNDED. THE EMPLOYEE PHLEBOTOMIST FKUSHED HER EYES WITH WATER AND THEN SOUGHT TREATMENT IN THE EMERGENCY DEPARTMENT. THE MFG REPRESENTATIVE WAS NOTIFIED AND THE REMAINING TUBES OF THE LOT IMPOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAMPOLE LABORATORIES ISOLATOR MICROBIAL TUBE JSC WAMPOLE LABORATORIES DIV, CASTER-WALLACE, INC. 017278

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention