BEUDAMED
    FDA Adverse Event Other Summary report: N

    TERUFLEX DOUBLE CPD/OPTISOL 450ML

    MDR report key: 2625932 · Received June 15, 2012

    Report

    Report Number
    1722028-2012-00361
    Event Type
    Other
    Date Received
    June 15, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 18, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    KSR
    Product Problem
    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)(4) FACTORIES WERE CHECKED FOR PROBLEMS RELATING TO THIS EVENT. NO ABNORMALITIES WERE FOUND. THE NEEDLE GUARDS OF 4 RETENTION SAMPLES FROM THE REFERENCED LOT 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 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 THE NEEDLE DID NOT PROPERLY WITHDRAW INTO THE SAFETY DEVICE. IT IS UNKNOWN AT THIS TIME IF A NEEDLESTICK OCCURRED AS A RESULT OF THIS EVENT. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION AT THIS TIME TO DETERMINE IF A DEVICE MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    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