BEUDAMED
    FDA Adverse Event Other Summary report: N

    TERUFLEX DOUBLE CPD/OPTISOL 450ML

    MDR report key: 2623097 · Received June 13, 2012

    Report

    Report Number
    1722028-2012-00312
    Event Type
    Other
    Date Received
    June 13, 2012
    Date of Event
    May 17, 2012
    Report Date
    May 18, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    KSR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: THE MANUFACTURING RECORDS FROM BOTH THE (B)(6) FACTORIES WERE CHECKED FOR PROBLEMS RELATING TO THIS EVENT. NO ABNORMALITIES WERE FOUND. THE NEEDLE GUARDS OF 4 RETENTION SAMPLES FROM THE REFERENCED LOT NUMBER WERE EXAMINED. NO ABNORMALITIES OR DEFORMATIONS WERE FOUND. ALSO, IT WAS CONFIRMED THAT THE NEEDLES RETRACTED FULLY INTO THE NEEDLE GUARDS. THE NEEDLES DID NOT COME OUT OF THE NEEDLE GUARD WHEN APPLYING FORCE TO THE TUBE AT THE BASE OF THE HUB IN THE DIRECTION OF THE EXPOSED NEEDLE TIP. ROOT CAUSE: THE DEVICE WAS NOT AVAILABLE FOR ROOT CAUSE ANALYSIS. SIMILAR INCIDENTS THAT HAVE BEEN REPORTED IN THE PAST, HAVE BEEN THE RESULT OF THE USER'S LACK OF EXPERIENCE WITH THE DEVICE. IT CANNOT BE RULED OUT THAT THE INCIDENT OCCURRED BY THE OPERATOR'S INCORRECT TECHNIQUE DURING USE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT UPON OBSERVATION OF THE NEEDLE SET LODGED IN THE SAFETY DEVICE, IT DID APPEAR THAT THE NEEDLE WAS SOMEWHAT SLANTED TOWARD THE RIGHT SIDE. THERE ARE 2 RIDGES THAT RUN THROUGH THE CENTER/TOP OF THE INSIDE OF THE SAFETY DEVICE. THE NEEDLE TIP ITSELF ENDED UP ALIGNED WITH THE RIGHT HAND RIDGE AS YOU LOOK INTO THE SAFETY DEVICE. NORMALLY THE NEEDLE LINES UP IN THE CENTER OF THE SAFETY DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EMPLOYEE GOT A NEEDLESTICK. SHE HELD THE NEEDLEGUARD STATIONARY WITH HER LEFT FOREFINGER AND THUMB. SHE POSITIONED NEEDLE HUB INTO THE SAFETY DEVICE. AS SHE PULLED ON THE TUBING TO WITHDRAW THE NEEDLE AND PULL IT BACK INTO THE NEEDLE GUARD, THE NEEDLE/HUB BECAME PARTIALLY LODGED IN THE SAFETY DEVICE TO PULL OUT OF HER GRASP, RECOIL, AND SUBSEQUENTLY STUCK HER LEFT FINGER. EMPLOYEE WAS SEEN IN EMERGENCY ROOM AS PART OF OUR OCCUPATIONAL EXPOSURE PROTOCOL. THE AGE AND WEIGHT OF THE EMPLOYEE PLACED AT RISK ARE UNKNOWN. DONOR INFORMATION: (B)(6), FEMALE. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO A NEEDLESTICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUFLEX DOUBLE CPD/OPTISOL 450ML BLOOD BAG KSR TERUMO BCT 111021GC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other