BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9617032-2017-00160

    MDR report key: 7075767 · Received December 1, 2017

    Report

    Report Number
    9617032-2017-00160
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 6, 2015
    Report Date
    November 6, 2017
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS SENT THAT SHOWS THE TEAR IN THE PACKAGE. THERE IS NO EVIDENCE AS TO HOW OR WHERE THE TEAR OCCURRED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5051055. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGE OF THE BD VACUTAINER® ECLIPSETM WITH SAFETY NEEDLE WAS TORN. NO SERIOUS INJURY OR MEDICAL INTERVENTIONS REPORTED. THE PROBLEM WAS DISCOVERED BEFORE USE.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other