BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE¿ 3ML LL W/NDL ECLIPSE¿ 22X1 RB

    MDR report key: 8465846 · Received March 29, 2019

    Report

    Report Number
    8041187-2019-00263
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 6, 2019
    Report Date
    April 1, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057888
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 2 PHOTOS WERE RETURNED FOR EVALUATION. FROM THE RETURNED PHOTOS IT WAS UNABLE TO DETERMINE THE NON-CONFORMANCE AS STATED. ROOT CAUSE COULD NOT BE DETERMINED AS IT WAS UNABLE TO OBSERVE THE NON-CONFORMANCE FROM THE RETURNED PHOTOS. DURING THE REVIEW OF DHR, THERE IS NO ABNORMALITY OBSERVED ON THE VISUAL INSPECTION PERFORMED DURING THE IN- PROCESS INSPECTION AND OUT-GOING INSPECTION. FOR THE DURATION OF 12 MONTHS, THERE IS NO QUALITY NOTIFICATION RAISED ON A SIMILAR NON-CONFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED BD SYRINGE¿ 3ML LL W/NDL ECLIPSE¿ 22X1 RB HAD A DISTORTED STOPPER.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K)#: K980987 (SYRINGE); 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 BD SYRINGE¿ 3ML LL W/NDL ECLIPSE¿ 22X1 RB HAD A DISTORTED STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260319 BD SYRINGE¿ 3ML LL W/NDL ECLIPSE¿ 22X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 7114289 30382903057888

    Patients

    Seq Age Sex Outcome Treatment
    1 Other