BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE

    MDR report key: 13956813 · Received March 30, 2022

    Report

    Report Number
    8041187-2022-00155
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 8, 2022
    Report Date
    May 5, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057802
    PMA / PMN Number
    K161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 29-MAR-2022. H.6. INVESTIGATION: ONE PHOTO AND ONE SYRINGE SAMPLE WITHOUT PACKAGING WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, BLACK INK WAS OBSERVED TO BE COVERING THE WHOLE SURFACE AREA OF THE SYRINGE BARREL UNTIL THE RETAINER RING FROM APPROXIMATELY 0.88ML SCALE MARKING ONWARDS. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION AND THE TEAM OBSERVED A BLACK INK STAIN COVERING THE SURFACE AREA OF THE SYRINGE BARREL UNTIL THE RETAINER RING FROM APPROXIMATELY 0.88ML SCALE MARKING ONWARDS. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. THE 1 ML SYRINGE PART IS MANUFACTURED AT BD CANAAN, AND THE BD CANAAN QUALITY HAS CONDUCTED A SUPPLEMENTAL INVESTIGATION ON THIS NONCONFORMANCE. THE TEAM DETERMINED THAT A POTENTIAL ROOT CAUSE FOR THE GROSS INK RINGS DEFECT IS ASSOCIATED WITH THE MARKING PROCESS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE DEVICE NAMES/TYPES AND 510K NUMBERS REPORTED TO BE INVOLVED. ADDITIONAL INFORMATION BELOW: MEDICAL DEVICE TYPE: FMF. COMMON DEVICE NAME: PISTON SYRINGE. PMA / 510(K) #: K941562. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE SCALE MARKINGS WERE BLURRED TOGETHER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SCALE BLUR."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE SCALE MARKINGS WERE BLURRED TOGETHER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SCALE BLUR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003534 BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305780 UNKNOWN 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown