BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL BLOCK TRAY

    MDR report key: 6567819 · Received May 15, 2017

    Report

    Report Number
    9611594-2017-00079
    Event Type
    Injury
    Date Received
    May 15, 2017
    Report Date
    July 7, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSP
    PMA / PMN Number
    K000495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT AVAILABLE AT THE TIME THIS REPORT WAS FILED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS AVAILABLE. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 12MAY2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 03AUG2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN THAT AN INCIDENT INVOLVING A BROKEN NEEDLE OCCURRED 8 YEARS AGO. DURING A PROCEDURE, THE 30 GAUGE 1 INCH HYPODERMIC NEEDLE BROKE OFF INTO A MALE PATIENT, AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM. THE PHYSICIAN STATED HE DOES NOT KNOW IF THE NEEDLE WAS RETRIEVED AS HE STOPPED FOLLOWING THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 07JUL2017 THAT STATES THE PHYSICIAN STATED HE RECALLED THE PATIENT WAS BETWEEN THE AGE OF 70-80 YEARS OLD. ADDITIONAL INFORMATION WAS RECORDED FROM THE PHYSICIAN ON 10JUL2017. THE PHYSICIAN STATED THE CALL ON 07-JUL-2017 WAS IN REFERENCE TO THE INCIDENT TO THE MALE PATIENT THAT OCCURRED 8 YEARS AGO. THE STATUS OF THE PATIENT IS CURRENTLY UNKNOWN AS THE PHYSICIAN NO LONGER FOLLOWED THE PATIENT. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348578 UNIVERSAL BLOCK TRAY PAIN MGMT KITS/TRAYS/NEEDLES BSP HALYARD HEALTH 181045 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention