BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD

    MDR report key: 9152044 · Received October 3, 2019

    Report

    Report Number
    1911916-2019-01043
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 13, 2019
    Report Date
    October 11, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    NGT
    UDI-DI
    00382903064991
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RECEIVED. IT HAS THE PLUNGER ROD-RUBBER STOPPER, NO TIP CAP, AND NO SALINE SOLUTION; THE PLUNGER ROD-RUBBER STOPPER IS ALL THE WAY DOWN. THE PLUNGER ROD IS NOT ATTACHED TO THE RUBBER STOPPER. NO MANUFACTURING ISSUES WERE EXPERIENCED DURING THE PRODUCTION OF THESE PRODUCTS. THE SYRINGE IS NOT DESIGNED TO DRAWING BLOOD. POSSIBLE ROOT CAUSE, OFF LABEL USE. THE SYRINGE IS DESIGNED TO FLUSH THE IV LINES BY PUSHING THE PLUNGER ROD DOWN, NOT TO DRAW BLOOD LAB SAMPLES BY PULLING THE PLUNGER ROD UP. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD HAS BEEN FOUND EXPERIENCING STOPPER SEPARATION FROM THE PLUNGER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE "BLACK RUBBER ON NS SYRINGE BECAME DISCONNECTED FROM PLUNGER WHILE TRYING TO WITHDRAW MY WASTE DURING LAB DRAW." CUSTOMER TEXT: CONCERN: BLACK RUBBER ON NS SYRINGE BECAME DISCONNECTED FROM PLUNGER WHILE TRYING TO WITHDRAW MY WASTE DURING LAB DRAW. I UNHOOKED THE SYRINGE AND HEPLOCKED THE IV AND GRABBED NEW SUPPLIES TO START OVER--AND HAD NO PROBLEMS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD HAS BEEN FOUND EXPERIENCING STOPPER SEPARATION FROM THE PLUNGER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE "BLACK RUBBER ON NS SYRINGE BECAME DISCONNECTED FROM PLUNGER WHILE TRYING TO WITHDRAW MY WASTE DURING LAB DRAW." CUSTOMER TEXT: CONCERN: BLACK RUBBER ON NS SYRINGE BECAME DISCONNECTED FROM PLUNGER WHILE TRYING TO WITHDRAW MY WASTE DURING LAB DRAW. I UNHOOKED THE SYRINGE AND HEPLOCKED THE IV AND GRABBED NEW SUPPLIES TO START OVER--AND HAD NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948223 SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD INTRAVASCULAR CATHETER NGT BECTON DICKINSON AND COMPANY 9018603 00382903064991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other