BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE

    MDR report key: 6153062 · Received December 7, 2016

    Report

    Report Number
    1030451-2016-00016
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 3, 2016
    Report Date
    December 5, 2016
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    OHG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RECEIVED ABOVE STATED REPORT ON 11/08/2016 REGARDING METAL FLAKES FROM HEMOSTAT COMPONENT FALLING ON PATIENT WOUND DURING CIRCUMCISION PROCEDURE. (B)(4) IS THE MANUFACTURER OF THE CONVENIENCE KIT WHICH CONTAINS THIS INSTRUMENT. THE HEMOSTAT INSTRUMENT, VENDOR NUMBER 160, IS MANUFACTURED IN (B)(4). UPON RECEIPT OF COMPLAINT, (B)(4) INITIATED AN INTERNAL COMPLAINT INVESTIGATION UNDER COMPLAINT (B)(4). WE OBTAINED THE INVOLVED SAMPLE FOR EVALUATION AND INITIATED A SUPPLIER CORRECTIVE ACTION REQUEST WITH THE MANUFACTURER OF THE INSTRUMENT. THE SUPPLIER, (B)(4), HAS RESPONDED THAT THE INSTRUMENT DID NOT APPEAR TO HAVE FULLY REMOVED THE CLEANING COMPOUND FROM THIS INSTRUMENT AT ONE LOCATION ON THE INSTRUMENT DURING ULTRASONIC MACHINE PRECLEANING PROCESSES. THE DEBRIS APPEARED TO BE CLEANING COMPOUND RATHER THAN METAL FLAKES. THE MANUFACTURER HAS EVALUATED THE PRECLEANING PROCESS AND EXTENDED INSTRUMENT TIME WITHIN ULTRASONIC CLEANING MACHINE TO FURTHER ENSURE ALL REMAINING MANUFACTURING DEBRIS IS FULLY REMOVED. THE SUPPLIER ADDITIONALLY DID INSPECT ALL INVENTORY AND DID NOT FIND ANY OTHER NONCONFORMING PRODUCT. MAI REVIEWED COMPLAINT HISTORY FOR THIS KIT AND INSTRUMENT AND FOUND NO OTHER SIMILAR COMPLAINTS OF THIS NATURE IN THE PAST THREE YEARS. MAI EVALUATED A LOT FROM CURRENT INVENTORY AS WELL AND FOUND NO NONCONFORMING PRODUCT. AT THIS TIME, THIS INSTANCE APPEARS TO BE ISOLATED IN NATURE.

    Description of Event or Problem · 1

    (B)(4) RECEIVED REPORT ON 11/03/2016 THAT A HEMOSTAT USED IN CIRCUMCISION PROCEDURE HAD SOME METAL FLAKE OFF DURING PROCEDURE. FOLLOW-UP WITH THE END-USER INDICATED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE INCIDENT. THE INSTANCE OCCURRED DURING USE OF INSTRUMENT AND THE FLAKES WERE ON PATIENT WOUND AND REMOVED BY PHYSICIAN. (B)(4) ASSEMBLED/MANUFACTURED THE INVOLVED CONVENIENCE KIT, CIR1005. IN THIS INSTANCE, THE HEMOSTAT INSTRUMENT INVOLVED WAS ORIGINALLY MANUFACTURED BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802652 MEDICHOICE CIRCUMCISION KIT OHG MEDICAL ACTION INDUSTRIES CIR1005 217987

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention