BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ SAFETY NEEDLES BD ECLIPSE¿ NEEDLE

    MDR report key: 13577449 · Received February 22, 2022

    Report

    Report Number
    8041187-2022-00090
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 4, 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

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 22-FEB-2022. H6: INVESTIGATION SUMMARY ONE PHOTO AND 76 SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. ON THE RETURNED PHOTO, THE PLUNGER STOP AT SCALE MARKING OF 0.5 ML FROM THE PHOTO WAS OBSERVED BUT THE TEAM WAS UNABLE TO PLUNGER MOVEMENT DIFFICULT NONCONFORMANCE. AS THE SAMPLES WERE MANUFACTURED AT BD CANAAN, FUNCTIONAL TESTING WAS NOT PERFORMED BY TUAS AS TO NOT DESTROY THE SAMPLES. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE QUALITY TEAM AT BD CANAAN HAS PERFORMED A SUPPLEMENTAL INVESTIGATION ON THE RETURNED SAMPLES. UPON EXERCISING THE 76 SAMPLES (52 UNSEALED PACKAGES AND 24 LOOSE), ALL PLUNGER RODS WERE SMOOTH TO DRAW, AND THE REPORTED DEFECT COULD NOT BE IDENTIFIED OR CONFIRMED IN THE SAMPLES RECEIVED. AS THE DEFECT COULD NOT BE CONFIRMED, A ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 76 BD ECLIPSE¿ SAFETY NEEDLES BD ECLIPSE¿ NEEDLE PLUNGERS WERE HARD TO PUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER IS HARD TO PUSH".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 76 BD ECLIPSE¿ SAFETY NEEDLES BD ECLIPSE¿ NEEDLE PLUNGERS WERE HARD TO PUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER IS HARD TO PUSH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881818 BD ECLIPSE¿ SAFETY NEEDLES BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305780 1204100 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown