BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD U F II 3/10CC 31G SYRINGE

    MDR report key: 1219491 · Received October 31, 2008

    Report

    Report Number
    1920898-2008-00024
    Event Type
    Injury
    Date Received
    October 31, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 30, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ISSUE - PLUNGER OF SYRINGE WAS OBSERVED TO MOVE FREELY WITHOUT RESISTANCE DURING INJECTION AND AFTER INJECTION, BLOOD GLUCOSE LEVELS STARTED TO GO UP. REPORT: REGULATORY COMPLIANCE RECEIVED ONE (1) LOOSE 3/10CC SYRINGE WHICH CUSTOMER CLAIMS WHILE INJECTION WITH THIS SYRINGE, THE PLUNGER MOVED DOWN FREELY WITH NO RESISTANCE AT ALL AND FOLLOWING INJECTION, BLOOD GLUCOSE LEVELS ROSE. THE CUSTOMER GAVE THE LOT# FOR THIS PRODUCT AS 8141664. THE SYRINGE WAS VISUALLY EXAMINED, AND NO ISSUES WERE OBSERVED. THE CANNULA WAS INSPECTED ALONG THE INJECTION LENGTH, FOR ANY CRACKS OR DAMAGE, BUT THE CANNULA WAS FOUND TO BE INTACT. THE SYRINGE WAS FURTHER EXAMINED UNDER UV LIGHT, AND THERE WAS SUFFICIENT ADHESIVE OBSERVED IN HUB; THEREFORE, NO LEAKAGE COULD TAKE PLACE THERE. THE SUSTAINING FORCE WAS THEN MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. FOLLOWING THIS, THE INNER DIAMETER OF THE CANNULA WAS CAREFULLY WIRED TO SEE IF IT WAS BLOCKED AS THIS COULD CAUSE A BUILD UP OF PRESSURE WHICH AFFECTS THE MOVEMENT OF THE PLUNGER. THE WIRE WENT THROUGH TO OTHER END WITHOUT ANY ISSUES. FINALLY, THE SYRINGE WAS EVALUATED BY DRAWING THE EXPELLING INSULIN AND THE SYRINGE PERFORMED AS PER SPECIFICATION. NO DEFECTS WERE FOUND OR NOTED WITH THE RETURNED SYRINGE. A DEVICE HISTORY REVIEW WAS ALSO CONDUCTED AND NO ANOMALIES WERE NOTED. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS NOTICING THAT THE PLUNGER OF THE SYRINGE BEING USED FOR AN INSULIN INJECTION, MOVED DOWN FREELY WITHOUT ANY RESISTANCE. THEN, AFTER INJECTION, THE BLOOD GLUCOSE LEVEL STARTED TO GO UP. A CALL WAS MADE TO THE DOCTOR WHO ADVISED THAT AN ADDITIONAL FOUR (4) UNITS OF INSULIN BE INJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD U F II 3/10CC 31G SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON NA 8141664

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention