BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE WITH BD ECLIPSE SAFETY THIN WALL NEEDLE

    MDR report key: 10434071 · Received August 20, 2020

    Report

    Report Number
    8041187-2020-00509
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 8, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057871
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FORTY-SEVEN REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THESE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR A CLOGGED NEEDLE. NO CLOGGED NEEDLES WERE OBSERVED, THEREFORE THE TEAM WAS UNABLE TO CONFIRM THE CUSTOMER EXPERIENCE AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY THIN WALL NEEDLE WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE WILL NOT PULL BACK".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980987 (SYRINGE), PMA / 510(K)#: K161170 (NEEDLE). 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 LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY THIN WALL NEEDLE WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE WILL NOT PULL BACK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899631 BD LUER-LOK SYRINGE WITH BD ECLIPSE SAFETY THIN WALL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305787 9235114 30382903057871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other