BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8041187-2017-00082

    MDR report key: 6819152 · Received August 24, 2017

    Report

    Report Number
    8041187-2017-00082
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    August 1, 2017
    Report Date
    August 24, 2017
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOR DEVICES WITHOUT 510(K) NUMBERS: PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION HOWEVER ONE PHOTO WAS EVALUATED. THE PICTURE SHOWED THE RUBBER SLEEVE DID NOT RECOVER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6172367. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A BLOOD DRAW WITH A BD FLASHBACK BLOOD COLLECTION NEEDLES 21G X 1 THE NON PATIENT END SLEEVE DIDN'T RECOVER. THE NURSE WASN'T WEARING GLOVES, AND LEAKED BLOOD ONTO THE NURSES HAND. THE NURSE CLEANED THE BLOOD IMMEDIATELY WITH STANDARD PRACTICE. NO MEDICAL INTERVENTIONS.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other