BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD SAFETY-LOK BLOOD COLLECTION SET

    MDR report key: 2987984 · Received January 11, 2013

    Report

    Report Number
    2243072-2013-00001
    Event Type
    Other
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    January 11, 2013
    Manufacturer
    BD
    Product Code
    KPE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THIS IS THE FIRST COMPLAINT REPORTED WITH REGARDS TO LOT NUMBER 2F1981. THE MFG AND INSPECTION RECORDS OF THE LOT CONCERNED WERE REVIEWED AND NO ABNORMALITY WHICH COULD BE RELATED TO THE REPORTED EVENT WAS FOUND. (B)(4) RETENTION SAMPLES WERE CHECKED VISUALLY AND NO ABNORMALITY SUCH AS DAMAGE AND/OR MOLDING (B)(4) RETENTION SAMPLES WERE TESTED FOR FUNCTIONAL INSPECTION (BREAKAWAY FORCE, SUSTAINING FORCE OR SECURITY FORCE) AND MET SPECIFICATIONS. (B)(4) UNUSED SAMPLES FROM REPORTED LOT NUMBER WERE RECEIVED ON (B)(4) 2013. SAMPLES RETURNED FROM CUSTOMER WILL BE ANALYZED. QUALITY WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    PHLEBOTOMIST REPORTED THAT UPON REMOVING THE NEEDLE FROM THE SYRINGE AFTER ACTIVATING THE SAFETY, THE NEEDLE WENT SIDEWAYS OF THE DEVICE AND THE HCW RECEIVED A NEEDLE STICK. PT WAS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19654 BD SAFETY-LOK BLOOD COLLECTION SET 25GX0.75"ND1X12"TUBE BLOOD COLLECTION SET KPE BD 2F1981

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other