BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE 3 ML - 21G 1 1/2 "

    MDR report key: 6843509 · Received September 5, 2017

    Report

    Report Number
    3003916417-2017-00035
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    August 11, 2017
    Report Date
    August 21, 2017
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. INVESTIGATION: (IDENTIFIED THE FOLLOWING OCCURENCES 1017/16 - DEVIATION OF GENERAL PROCESSES (THERE ARE NO MAINTENANCE OCCURENCES IN THIS BATCH). EVALUATING THE IMAGES PROVIDED BY THE CUSTOMER, IT IS POSSIBLE IDENTIFY FOREIGN MATTER ¿ RESIN. ROOT CAUSE: WERE EVALUATED THE RECORDS OF THE BATCH AND THE VISUAL EVALUATION OF THE IMAGES. DURING THE BATCH PRODUCTION THERE WERE NO RECORDS OF OCCURRENCES RELATED TO THIS DEFECT ARE OBSERVED, HOWEVER AFTER THE ANALYSIS OF THE IMAGE IT IS POSSIBLE CONFIRM FOREIGN MATTER ¿ RESIN. AFTER THIS EVALUATION IT CAN BE VERIFIED THAT IS AN INDIVIDUAL OCCURRENCE POTENTIALLY RELATED TO A FAIL AT RESIN APPLICATION (USED TO JOIN THE CANNULA AND HUB) WERE OCCURRED ONE SPLASH OF RESIN AT CANNULA. CONCLUSION: EVALUATING THE IMAGE PROVIDED BY THE CUSTOMER, IT IS POSSIBLE TO IDENTIFY FOREIGN MATTER ¿ RESIN AT CANNULA. EVALUATING THE POTENTIAL CAUSES FOR THE PROBLEM IS VERIFIED A POSSIBLE FAIL AT RESIN APPLICATION (USED TO JOIN THE CANNULA AND HUB) WERE OCCURRED ONE SPLASH OF RESIN AT CANNULA. THE DEFECT IDENTIFIED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND EVALUATION. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE FAILURE MODE INDICATED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE 3 ML - 21G 1 1/2 ", BEFORE USE. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621175 BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE 3 ML - 21G 1 1/2 " SYRINGE WITH NEEDLE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 6300147

    Patients

    Seq Age Sex Outcome Treatment
    1 Other