BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SYRINGE¿ 5ML LL W/NEEDLE 22X1-1/2IN RB

    MDR report key: 8373932 · Received February 27, 2019

    Report

    Report Number
    9610847-2019-00188
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    February 11, 2019
    Report Date
    May 3, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMI
    UDI-DI
    00382903057856
    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: DHR FOR LOT NUMBER 8029598 WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. THE SAMPLE RECEIVED WAS VISUALLY INSPECTED AND IT SHOWS THE NEEDLE NOT COMPLETELY COVERED BY THE SAFETY COVER CAUSING TO HAVE THE TIP OF THE NEEDLE EXPOSED AND CAUSING THAT THE NURSE GET STUNK, THE CAUSE OF THE TIP EXPOSURE WAS DUE THAT THE SAFETY COVER WAS NOT MOLDED CORRECTLY, ON THIS ORDER IT GET INSPECTED AND PACKED 100,860 SYRINGES WITH NEEDLES AND DURING THE INSPECTION NO NEEDLE EXPOSURE WERE FOUND ON THE MATERIAL. WITH THIS CONDITION WE CAN CONFIRM THE ISSUE STATED BY THE CUSTOMER WITH THE SAMPLE RECEIVED FROM CUSTOMER, AFTER THAT WE INSPECT THE RETAIN SAMPLES, ON THIS CASE WE DID NOT FIND ANY FAILURE AS THE ONE SHOWED ON THE SAMPLE RECEIVED FROM THE CUSTOMER, WE CAN ASSIGN THIS ISSUE AS RAW MATERIAL ISSUE FROM SUPPLIER, THIS DEFECT COULD NOT BE OBSERVED DURING THE INSPECTION PROCESS DUE THAT THE NEEDLE HAS A SECOND COVER AND THERE IS NO WAY TO CHECK IF THE MAIN COVER IT IS PLACED CORRECTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE¿ 5ML LL W/NEEDLE 22X1-1/2IN RB SAFETY SHIELD DID NOT COMPLETELY COVER NEEDLE WHICH RESULTED IN THE NURSE BEING STUCK BY THE NEEDLE.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K)#: K980987 (SYRINGE); K161170 (NEEDLE). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SYRINGE¿ 5ML LL W/NEEDLE 22X1-1/2IN RB SAFETY SHIELD DID NOT COMPLETELY COVER NEEDLE WHICH RESULTED IN THE NURSE BEING STUCK BY THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169630 BD SYRINGE¿ 5ML LL W/NEEDLE 22X1-1/2IN RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8029598 00382903057856

    Patients

    Seq Age Sex Outcome Treatment
    1 Other