BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1024879-2017-00037

    MDR report key: 6445017 · Received March 29, 2017

    Report

    Report Number
    1024879-2017-00037
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    March 8, 2017
    Report Date
    May 5, 2017
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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 # 5120699. 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.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DRAWING A PATIENT'S BLOOD, THERE WAS AN AUDIBLE SNAP AND THE NEEDLE OF A 21 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 7 IN. TUBING AND LUER ADAPTER RETRACTED PREMATURELY. THE USER WAS UNCERTAIN IF THE NEEDLE HAD ACTUALLY RETRACTED OR IF IT HAD BROKEN OFF INSIDE THE PATIENT'S VEIN. A PHYSICIAN WAS CONSULTED AND THE PATIENT WAS EVALUATED. THE PATIENT RECEIVED AN X-RAY AND A BROKEN NEEDLE WAS NOT SEEN WITHIN THE PATIENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention