BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB

    MDR report key: 9828446 · Received March 13, 2020

    Report

    Report Number
    1213809-2020-00185
    Event Type
    Malfunction
    Date Received
    March 13, 2020
    Date of Event
    January 30, 2020
    Report Date
    March 27, 2020
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO OF TWO LOOSE SAFETYGLIDE NEEDLE ASSEMBLIES WAS RECEIVED AND EVALUATED. IT WAS OBSERVED ONE WAS UNSHIELDED WITH THE SAFETY SHIELD ACTIVATED AND APPEARED TO HAVE A MISSING CANNULA. ONE WAS INSIDE THE SHIELD AND THE CANNULA APPEARED TO BE SIGNIFICANTLY CURVED. BOTH NEEDLE ASSEMBLIES WERE REJECTABLE PER PRODUCT SPECIFICATION. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE SAFETYGLIDE NEEDLE ASSEMBLY PROCESS. THE FIXTURE HOLDING THE NEEDLE ASSEMBLY WAS NOT PERFECTLY CENTERED WHEN THE PLASTIC SHIELD WAS ASSEMBLED INDUCING THE BENT NEEDLE. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8002868 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE SFTYGLD 25X1 RB WAS BENT AND ANOTHER HAD A MOLDING DEFECT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOMETIME AROUND THE END OF JANUARY A BD SAFETY NEEDLE 25G 1" LOT #8002868, EXP 12/31/2022 WAS TAKEN OUT OF THE CAP AND FOUND TO HAVE A BENT NEEDLE. SHORTLY THEREAFTER, A SECOND ISSUE WAS FOUND WITH A NEEDLE WHERE THE NEEDLE HUB WAS MALFORMED, SAME LOT# AND EXP. I HAVE KEPT BOTH NEEDLES. WE HAVE PULLED THE INVENTORY WITH MATCHING LOT/EXP."

    Additional Manufacturer Narrative · 1

    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 A NEEDLE SFTYGLD 25X1 RB WAS BENT AND ANOTHER HAD A MOLDING DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOMETIME AROUND THE END OF JANUARY A BD SAFETY NEEDLE 25G 1" LOT #8002868, EXP 12/31/2022 WAS TAKEN OUT OF THE CAP AND FOUND TO HAVE A BENT NEEDLE. SHORTLY THEREAFTER, A SECOND ISSUE WAS FOUND WITH A NEEDLE WHERE THE NEEDLE HUB WAS MALFORMED, SAME LOT# AND EXP. I HAVE KEPT BOTH NEEDLES. WE HAVE PULLED THE INVENTORY WITH MATCHING LOT/EXP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295747 NEEDLE SFTYGLD 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 8002868 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other