BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE NEEDLE

    MDR report key: 11198421 · Received January 19, 2021

    Report

    Report Number
    1213809-2021-00026
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 28, 2020
    Report Date
    February 12, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SIXTEEN SAFETYGLIDE NEEDLE ASSEMBLIES WERE RECEIVED AND EVALUATED. FIFTEEN WERE IN FULLY SEALED BLISTER PACKS FROM BATCH 9150898 (P/N 305916). ONE WAS LOOSE AND ATTACHED TO AN UNKNOWN GLASS SYRINGE. IT WAS OBSERVED ON THE LOOSE NEEDLE ASSEMBLY, THE CANNULA WAS MISSING, AND SMALL PORTION OF THE HUB WAS BROKEN OFF AT THE CONNECTION POINT BETWEEN THE HUB AND CANNULA. THE MISSING CANNULA WAS REJECTABLE PER PRODUCT SPECIFICATION. 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 MISSING CANNULA DEFECT IS ASSOCIATED WITH THE ASSEMBLY LINE. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE EPOXY TO FIX IT; AFTER THAT, THE SAFETY MECHANISM AND THE PLASTIC SHIELD ARE ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE LACK OR NOT ENOUGH EPOXY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE BROKE OFF INTO THE PATIENT'S ARM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ADMINISTERING FLUSHOT; NEEDLE BROKE OFF IN PATIENTS ARM; REMAINDER OF BOX TAKEN OUT OF CIRCULATION".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE BROKE OFF INTO THE PATIENT'S ARM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ADMINISTERING FLUSHOT; NEEDLE BROKE OFF IN PATIENTS ARM; REMAINDER OF BOX TAKEN OUT OF CIRCULATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88674 BD SAFETYGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 9150898 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1