BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8732666 · Received June 25, 2019

    Report

    Report Number
    8041187-2019-00487
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    June 7, 2019
    Report Date
    July 8, 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 RECEIVED FOR INVESTIGATION AND UNABLE TO OBSERVE DISTORTED STOPPER FROM THE PHOTOS. UNABLE TO OBSERVE DISTORTED STOPPER FROM THE RECEIVED PHOTOS. ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE IT WAS NOTICED THAT THE STOPPER WAS DEFORMED WITH A BD SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTORTED STOPPER.

    Additional Manufacturer Narrative · 1

    PMA / 510(K)#: K980987(SYRINGE); K161170 (NEEDLE). (B)(6). 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 PRIOR TO USE IT WAS NOTICED THAT THE STOPPER WAS DEFORMED WITH A BD SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTORTED STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526169 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