BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11625008 · Received April 6, 2021

    Report

    Report Number
    8041187-2021-00253
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    February 2, 2021
    Report Date
    April 12, 2021
    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
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY THIN WALL NEEDLE LEAKED FROM THE NEEDLE HUB AND SYRINGE JUNCTION DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT WAS SEEN M CLINIC FOR A THUMB INJECTION 3CC SYRINGE AND 25 GAUGE 1.5"NEEDLE WAS USED. THE NEEDLE WAS PLACED INTO THE JOINT AND WHEN INJECTING THE MIXTURE AN UNKNOWN QUANTITY OF THE MIXTURE LEAKED OUT OF THE JUNCTION OF THE NEEDLE AND THE SYRINGE HUB. ONCE THE FIRST DROPS WERE NOTICED THE NEEDLE WAS RETIGHTENED INTO THE HUB BUT MIXTURE CONTINUED TO LEAK OUT LIKELY MOST OF THE MATERIAL LEAKED OUT IN THE END, RATHER THAN BEING INJECTED."

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH # (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY THIN WALL NEEDLE LEAKED FROM THE NEEDLE HUB AND SYRINGE JUNCTION DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT WAS SEEN M CLINIC FOR A THUMB INJECTION 3CC SYRINGE AND 25 GAUGE 1.5"NEEDLE WAS USED. THE NEEDLE WAS PLACED INTO THE JOINT AND WHEN INJECTING THE MIXTURE AN UNKNOWN QUANTITY OF THE MIXTURE LEAKED OUT OF THE JUNCTION OF THE NEEDLE AND THE SYRINGE HUB. ONCE THE FIRST DROPS WERE NOTICED THE NEEDLE WAS RETIGHTENED INTO THE HUB BUT MIXTURE CONTINUED TO LEAK OUT LIKELY MOST OF THE MATERIAL LEAKED OUT IN THE END, RATHER THAN BEING INJECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517585 BD LUER-LOK SYRINGE WITH BD ECLIPSE SAFETY THIN WALL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305787 UNKNOWN 30382903057871

    Patients

    Seq Age Sex Outcome Treatment
    1