BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 8019725 · Received October 30, 2018

    Report

    Report Number
    1213809-2018-00718
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 10, 2018
    Report Date
    December 13, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059189
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THREE PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS DEPICTED A SEALED PACKAGED SAFETYGLIDE NEEDLE, CONFIRMED TO BE FROM BATCH #8143757 (P/N 305918). THE NEEDLE IN THE PACKAGE DID NOT HAVE A SHIELD AND THE NEEDLE¿S SHARP TIP WAS OBSERVED STICKING OUT THROUGH THE BOTTOM WEB OF THE PACKAGE. A STICKY NOTE IN ANOTHER PHOTO APPEARS TO HAVE READ ¿THIS NEEDLE WAS FOUND WITHOUT THE SAFETY.¿ A PHYSICAL SAMPLE WAS RECEIVED. THE SAMPLE APPEARED TO BE THE SAME PACKAGED NEEDLE AS THE ONE DEPICTED IN THE PHOTO WITH THE UNSHIELDED CANNULA AND ITS TIP SLIGHTLY STICKING OUT OF THE BOTTOM WEB. 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. POTENTIAL ROOT CAUSE FOR THE MISSING SHIELD DEFECT IS ASSOCIATED WITH THE NEEDLE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD SAFETYGLIDE NEEDLE WAS MISSING THE CAP IN THE PACKAGE. THE NEEDLE STUCK THROUGH THE PACKAGE CREATING A STERILITY BREACH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD SAFETYGLIDE¿ NEEDLE WAS MISSING THE CAP IN THE PACKAGE. THE NEEDLE STUCK THROUGH THE PACKAGE CREATING A STERILITY BREACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861455 BD SAFETYGLIDE¿ NEEDLE NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 8143757 30382903059189

    Patients

    Seq Age Sex Outcome Treatment
    1 Other