BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 12715555 · Received October 28, 2021

    Report

    Report Number
    1213809-2021-00730
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 13, 2021
    Report Date
    October 7, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059035
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. MEDICAL DEVICE TYPE: FMI. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980580 (SYRINGE) .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. 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. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE THERE WAS FOREIGN MATTER ON THE DEVICE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLACK FOREIGN MATTER WAS FOUND IN THE NEEDLE DURING PRE-USE INSPECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613272 BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 305903 0325431 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1