BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ORALPAK ¿ ORAL DOSER

    MDR report key: 7113176 · Received December 13, 2017

    Report

    Report Number
    3003916417-2017-00106
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 21, 2017
    Report Date
    November 30, 2017
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER PHONE#: (B)(6). INVESTIGATION: INVESTIGATION SUMMARY: IT WAS PERFORMED THE DHR, QUALITY NOTIFICATION AND MAINTENANCE ANALYSIS AND NO DEVIATION WAS FOUND FOR THIS BATCH. IT WAS ANALYZED THE SAMPLE SENT BY THE CUSTOMER AND IT WAS POSSIBLE TO IDENTIFY THE DEFECT INFORMED, CONFIRMING THE DEFECT. BD HAS A SYSTEM OF GOOD MANUFACTURING PRACTICES IN WHICH OPERATORS RECEIVE GUIDELINES ESTABLISHED IN THE QUALITY PROCEDURES RELATED TO THE CLEANING AND CONSERVATION OF THE FACTORY, WITH CLEANING AND SANITIZING ACTIONS OF THE MANUFACTURING AREAS ESTABLISHED IN GG 048 0 IBW, PROCEDURES ON AND HYGIENE, WHICH MENTION THAT ONLY ALLOWED TO ENTER PLACES OF MANUFACTURE WITH THE USE OF APPROPRIATE GOWNING ((B)(6)) AND AFTER THE HYGIENE OF THE HANDS TO AVOID CONTAMINATIONS. THE USE OF CORRECT GOWNING INHIBITS THE POSSIBILITY THAT SOME EXTERNAL DIRT IS CARRIED INTO THE PRODUCTIVE AREA. ALSO AS ESTABLISHED BY THE PROCEDURE GG 028 0 RQS IS PROHIBITED THE ENTRY AND CONSUMPTION OF FOOD, USE OF ACCESSORIES OR BELONGINGS IN THE PRODUCTION AREA, THUS AVOIDING THE PRESENCE OF SUBSTRATES IN THE MANUFACTURING PROCESS. THEREFORE, WE TREAT THIS SITUATION AS SOMETHING PUNCTUAL AND NON-RECURRENT IN THE MANUFACTURING PROCESS. FROM THIS INFORMATION IT IS NOT POSSIBLE CONFIRM THE COMPLAINT. THE DEFECT IDENTIFIED BY THIS COMPLAINT WILL BE MONITORED TO TENDENCY ANALYSIS. INVESTIGATION CONCLUSION: BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENT IN QUESTION. IT WAS RECEIVED SAMPLES TO ANALYSIS, BEING POSSIBLE IDENTIFY THE DEFECT INFORMED. ROOT CAUSE DESCRIPTION: THIS A PUNCTUAL DEFECT, NOT BEING POSSIBLE DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE A BD ORALPAK ¿ ORAL DOSER BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890976 BD ORALPAK ¿ ORAL DOSER ORAL SYRINGE KYW BECTON DICKINSON IND. CIRURGICAS LTDA 7144595

    Patients

    Seq Age Sex Outcome Treatment
    1 Other