BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMAX PLUS PLASMA CONCENTRATOR W/GPS III PLASMA CONCENTRATOR TUBE W/30ML ACD-A

    MDR report key: 1708857 · Received June 3, 2010

    Report

    Report Number
    1825034-2010-00191
    Event Type
    Injury
    Date Received
    June 3, 2010
    Report Date
    May 4, 2010
    Manufacturer
    BIOMET BIOLOGICS
    Product Code
    LOQ
    PMA / PMN Number
    BK070026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE - UNKNOWN; EXPIRATION DATE - UNKNOWN, AS NO LOT IDENTIFICATION WAS PROVIDED. MANUFACTURE DATE - UNKNOWN, AS NO LOT IDENTIFICATION WAS PROVIDED. ALTHOUGH THE PRODUCT IDENTIFICATION WAS NOT PROVIDED, SALES HISTORY WAS REVIEWED TO DETERMINE WHICH LOTS OF THE KITS WERE SOLD TO THE USER FACILITY. IT WAS FURTHER DETERMINED WHAT NEEDLE LOTS WERE INCLUDED IN THE KITS. FIVE NEEDLE LOTS WERE IDENTIFIED, AND A SAMPLE FROM FOUR OF THE FIVE NEEDLE LOTS WAS EVALUATED. THERE WAS NO PRODUCT AVAILABLE FROM THE FIFTH LOT. EVALUATION OF THE NEEDLES FOUND THAT THEY FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PLASMA CONCENTRATION KIT WAS UTILIZED DURING A PROCEDURE. UPON DISPOSAL OF THE NEEDLE AND TUBING THAT WAS PROVIDED IN THE KIT, A NURSE WAS STUCK WITH A NEEDLE. IT WAS FURTHER REPORTED THAT THE CORRECT METHOD OF DISPOSAL IS TO ENSURE THAT THE NEEDLE IS SHEATHED AND IS PLACED INTO THE SHARPS CONTAINER FIRST WITH ANYTHING ELSE FOLLOWING. IN THIS INSTANCE, THE PROPER STEPS FOR DISPOSAL WERE NOT FOLLOWED AND THE TUBING WAS PLACED INTO THE SHARPS CONTAINER FIRST AND THE NURSE DID NOT ENSURE THAT THE SHEATH WAS PROPERLY ENGAGED. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMAX PLUS PLASMA CONCENTRATOR W/GPS III PLASMA CONCENTRATOR TUBE W/30ML ACD-A SUPPLIES, HEMATOLOGY LOQ BIOMET BIOLOGICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other