BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 9105009 · Received September 23, 2019

    Report

    Report Number
    1213809-2019-00956
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    September 5, 2019
    Report Date
    December 18, 2019
    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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAFETYGLIDE NEEDLE ASSEMBLY IN AN OPENED BLISTER PACK FROM BATCH 9052514 (P/N 305918) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE SAMPLE WAS MANIPULATED FROM THE RED PARTICLES, THAT APPEARED TO BE BLOOD, PRESENT THROUGHOUT THE NEEDLE ASSEMBLY AND PACKAGING. FROM VISUAL EXAMINATION OF THE SAMPLE, IT WAS NOTICED THE CANNULA WAS SEPARATED FROM THE HUB AND THE EPOXY DID NOT COMPLETELY COVER THE OUTER DIAMETER OF THE CANNULA. THE SEPARATION OF THE CANNULA AND HUB WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE CANNULA SEPARATION DEFECT IS ASSOCIATED WITH THE NEEDLE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. A MACHINE MALFUNCTION CAUSED INSUFFICIENT EPOXY TO BE APPLIED TO THE NEEDLE HUB / CANNULA ASSEMBLY WHICH RESULTED IN THE CANNULA NOT BEING SECURED IN THE NEEDLE HUB.

    Description of Event or Problem · 0

    MATERIAL NO: 305918, BATCH NO: 9052514. IT WAS REPORTED THAT DURING USE OF THE BD SAFETYGLIDE¿ NEEDLE THE NEEDLE DISCONNECTED DURING THE SAFETY ACTIVATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE DISCONNECTED DURING THE SAFETY ACTIVATION.

    Additional Manufacturer Narrative · 1

    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

    MATERIAL NO: 305918. BATCH NO: 9052514. IT WAS REPORTED THAT DURING USE OF THE BD SAFETYGLIDE¿ NEEDLE THE NEEDLE DISCONNECTED DURING THE SAFETY ACTIVATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE DISCONNECTED DURING THE SAFETY ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901680 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 9052514 30382903059189

    Patients

    Seq Age Sex Outcome Treatment
    1 Other