BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE II¿ INSULIN SYRINGE

    MDR report key: 4925786 · Received July 16, 2015

    Report

    Report Number
    2243072-2015-00128
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 30, 2015
    Report Date
    September 15, 2015
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K955235
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVAL. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION, HOWEVER PHOTOS OF THE DEVICE WERE RECEIVED. A PHOTO INSPECTION REVEALED THAT A NEEDLE HAD PIERCED THROUGH ITS NEEDLE COVER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4120578. CONCLUSION: ALTHOUGH THE PHOTO CONFIRMED THAT A NEEDLE HAD PIERCED THROUGH ITS NEEDLE COVER, WITHOUT A SAMPLE AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    RESULTS: 10 OPENED/LOOSE SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL ANALYSIS REVEALED THAT THE ONE OF THE 10 UNITS HAD A NEEDLE THAT HAD PIERCED THROUGH ITS NEEDLE COVER. AS PREVIOUSLY REPORTED, A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4120578. CONCLUSION: ALTHOUGH THE RETURNED SAMPLE CONFIRMED THAT A NEEDLE HAD PENETRATED ITS NEEDLE COVER, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LONDON PHARMACY EMPLOYEE RECEIVED A NEEDLE STICK INJURY FROM A BD ULTRA-FINE II (SHORT) SELF-CONTAINED INSULIN SYRINGE. A PHARMACY CUSTOMER HAD PURCHASED A PACKAGE OF 10 SYRINGES, LEFT THE PHARMACY, AND SHORTLY THERE AFTER BROUGHT THE SYRINGES BACK TO EXCHANGE THEM FOR A BIGGER SIZE. LATER IN THE EVENING, THE PHARMACY EMPLOYEE PULLED THE RETURNED PACKAGE TO SELL TO ANOTHER CUSTOMER AND PRICKED HERSELF ON ONE OF THE NEEDLES IN THE SEALED PACKAGE. THE NEEDLE HAD POKED THROUGH THE ORANGE CAP. THE PHARMACY EMPLOYEE RECEIVED A TETANUS IMMUNIZATION AT THE PHARMACY AND THEN WENT TO AN EMERGENCY DEPARTMENT TO BE EVALUATED. WHILE IN THE ER SHE RECEIVED A (B)(6) IMMUNIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PHARMACY EMPLOYEE RECEIVED A NEEDLE STICK INJURY FROM A BD ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE. A PHARMACY CUSTOMER HAD PURCHASED A PACKAGE OF 10 SYRINGES, LEFT THE PHARMACY, AND SHORTLY THERE AFTER BROUGHT THE SYRINGES BACK TO EXCHANGE THEM FOR A BIGGER SIZE. LATER IN THE EVENING, THE PHARMACY EMPLOYEE PULLED THE RETURNED PACKAGE TO SELL TO ANOTHER CUSTOMER AND PRICKED HERSELF ON ONE OF THE NEEDLES IN THE SEALED PACKAGE. THE NEEDLE HAD POKED THROUGH THE ORANGE CAP. THE PHARMACY EMPLOYEE RECEIVED A TETANUS IMMUNIZATION AT THE PHARMACY AND THEN WENT TO AN EMERGENCY DEPARTMENT TO BE EVALUATED. WHILE IN THE ER SHE RECEIVED A (B)(6) IMMUNIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463508 BD ULTRA-FINE II¿ INSULIN SYRINGE INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 4120578

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention