BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1710034-2017-00013

    MDR report key: 6271435 · Received January 23, 2017

    Report

    Report Number
    1710034-2017-00013
    Event Type
    Malfunction
    Date Received
    January 23, 2017
    Date of Event
    January 11, 2017
    Report Date
    March 10, 2017
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6223805. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF A 23 G X .75 IN. BD VACUTAINER WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN. TUBING WOULD NOT RETRACT DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other