BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE PLASTIPAK 1ML INSULIN S/SU

    MDR report key: 10117471 · Received June 4, 2020

    Report

    Report Number
    3003916417-2020-00160
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    May 19, 2020
    Report Date
    May 19, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: AS PER ATTACHED INVESTIGATION COMPLETED BY MANUFACTURING, "IT WAS NOT POSSIBLE PERFORMED THE DHR, DUE LOT NUMBER IS UNKNOW.. INVESTIGATION CONCLUSION: THE IMAGE SENT BY THE CUSTOMER WAS VERIFIED AND IT WAS POSSIBLE OBSERVE SCALE MARKING MISSING ROOT CAUSE DESCRIPTION: ACCORDING THE PROCESS EVALUATION THE PROBABLE CAUSE FOR THE DEFECT IS RELATED TO BREAKAGE OF PRINTING TOOL, ALLOWING THE FAIL PRODUCT FLOW OF THE PROCESS. THE INCIDENT IDENTIFIED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND EVALUATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE PLASTIPAK 1ML INSULIN S/SU WAS MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A TECHNICAL COMPLAINT AT OUR INSTITUTION REGARDING THE PRODUCT SYRINGE WITHOUT NEEDLE, LOT 145663, REF. 990256. THE NOTIFICATION INFORMS THAT THE SYRINGE CAME WITH THE BODY WITHOUT THE GRADUATION. UNFORTUNATELY, THE FACT WAS ONLY NOTICED AFTER TAMPERING WITH THE PACKAGING. * LOT NOT FOUND IN THE SYSTEM *"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585447 SYRINGE PLASTIPAK 1ML INSULIN S/SU INSULIN SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other