BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9617032-2017-00005

    MDR report key: 6339915 · Received February 17, 2017

    Report

    Report Number
    9617032-2017-00005
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    January 25, 2017
    Report Date
    March 10, 2017
    PMA / PMN Number
    K022426
    Removal / Correction Number
    MSS-16-837-FA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EIGHT UNUSED SAMPLE WERE RETURNED FOR EVALUATION. ALL UNITS WERE TESTED FOR SAFETY SHIELD DEFECTS AND ALL ACTIVATED CORRECTLY WITH NONE DETACHING. A REVIEW OF THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6203666. CONCLUSION: 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. ADDITIONALLY, OUR QUALITY ENGINEER NOTES THAT A POTENTIAL CAUSE FOR THIS TYPE OF DEFECT IS THAT LATERAL PRESSURE WAS PLACED ON THE SHIELD WHILE IT WAS BEING PUSHED INTO PLACE. THIS CAN HAVE THE EFFECT OF PUSHING THE SHIELD OUT OF THE PIVOT.

    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. REMEDICAL ACTION REQUIRED: FIELD ACTION NOTIFICATION MSS-16-837-FA AND CAPA (B)(4) WERE INITIATED FOR AN INCREASED NUMBER OF CUSTOMER COMPLAINTS REPORTING SAFETY COVER DISENGAGEMENT AND NEEDLE STICK INJURY FOR THE BD ECLIPSE¿ NEEDLE. BASED ON THE CUSTOMER REPORTS, IN SOME CASES WHEN THE SAFETY COVER IS PUSHED OVER THE NEEDLE IT DISENGAGES, RESULTING IN AN EXPOSED NEEDLE WHICH CAN INCREASE THE RISK OF NEEDLE STICK INJURY. ALSO, SOME CUSTOMER REPORTS INDICATE AN AUDIBLE ¿CLICK¿ SOUND BEFORE THE SAFETY COVER IS LOCKED (ACTIVATED) FOLLOWED BY A SECOND ¿CLICK¿ SOUND WHEN THE SAFETY COVER IS LOCKED OVER THE NEEDLE. A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016. UDI #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAREGIVER SUFFERED A CONTAMINATED NEEDLE STICK INJURY FROM A BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE 1.6ML DRAW/0.5X16MM (25G) FOLLOWING AN ARTERIAL SAMPLING. THE CAREGIVER ATTEMPTED TO ACTIVATE THE SAFETY MECHANISM ON A TABLE INSTEAD OF BY HAND AND THE SAFETY DID NOT ENGAGE. THE CAREGIVER DID NOT RECEIVE ANY MEDICAL INTERVENTIONS FOR THE BLOOD EXPOSURE AS THE SOURCE PATIENT'S HISTORY WAS KNOWN.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other