BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 8019917 · Received October 30, 2018

    Report

    Report Number
    1213809-2018-00775
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 7, 2018
    Report Date
    January 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TYPE OF REPORTABLE EVENTS: CORRECTED TO "SERIOUS INJURY".

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED WHERE THE DEVICE COULD HAVE ORIGINATED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 8002868. D.4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2022. H.4. DEVICE MANUFACTURE DATE: 1/2/2018. D.4. MEDICAL DEVICE LOT #: 7271580. D.4. MEDICAL DEVICE EXPIRATION DATE: 9/30/2022. H.4. DEVICE MANUFACTURE DATE: 9/28/2017. H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFETYGLIDE NEEDLE HAD SAFETY SYSTEM FAILURE THAT LED TO A NEEDLE STICK INJURY. IT WAS REPORTED THAT "THE PLASTIC WAS STUCK WHEN ACTIVATING THE SAFETY NEEDLE" AND THAT THE NEEDLE STICK OCCURRED AFTER THE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLE HAD SAFETY SYSTEM FAILURE THAT LED TO A NEEDLE STICK INJURY. IT WAS REPORTED THAT "THE PLASTIC WAS STUCK WHEN ACTIVATING THE SAFETY NEEDLE" AND THAT THE NEEDLE STICK OCCURRED AFTER THE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLE HAD SAFETY SYSTEM FAILURE THAT LED TO A NEEDLE STICK INJURY. IT WAS REPORTED THAT "THE PLASTIC WAS STUCK WHEN ACTIVATING THE SAFETY NEEDLE" AND THAT THE NEEDLE STICK OCCURRED AFTER THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861324 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other