BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 8107201 · Received November 27, 2018

    Report

    Report Number
    3003916417-2018-00335
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    November 7, 2018
    Report Date
    February 25, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463000378
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DHR, QUALITY NOTIFICATION AND MAINTENANCE ANALYSIS WERE PERFORMED AND NO OCCURRENCES POTENTIALLY RELATED TO THE DEFECT WAS OBSERVED. THE SAMPLE PROVIDED FOR BATCH 6133187 MANUFACTURED AT BD CURITIBA PLANT WAS EVALUATED AND MEET THE DIMENSIONAL REQUIREMENTS ACCORDING TO PRODUCT DRAWING. BASED ON THIS EVALUATION IT WAS NOT POSSIBLE CONFIRM THE OCCURRENCE.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 6133187. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2016-05-31.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PLASTIPAK¿ SYRINGE HAD SCALE MARKING ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PLASTIPAK SYRINGE HAD SCALE MARKING ERROR.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD PLASTIPAK¿ SYRINGE HAD SCALE MARKING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948895 BD PLASTIPAK¿ SYRINGE SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 6133187 07891463000378

    Patients

    Seq Age Sex Outcome Treatment
    1 Other