BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE PLASTIPAK 20ML LL S/SU

    MDR report key: 9219947 · Received October 22, 2019

    Report

    Report Number
    3003916417-2019-00532
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    October 7, 2019
    Report Date
    November 12, 2019
    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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DHR, QUALITY NOTIFICATION AND MAINTENANCE ANALYSIS WERE PERFORMED AND THE OCCURRENCE POTENTIALLY RELATED TO THE OCCURRENCE WAS OBSERVED. THE SAMPLE SENT BY THE CUSTOMER WAS VERIFIED AND IT WAS POSSIBLE TO OBSERVE STOPPER WITH ASSEMBLY FAILURE. THE PROBABLE CAUSE FOR THE OCCURRENCE IS RELATED TO FAILURE AT STOPPER ASSEMBLY STATION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE PLASTIPAK 20ML LL S/SU EXPERIENCED STOPPER DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO NOTIFY 1 BD LUER-LOK 20 ML SYRINGE UNIT, WHICH CAME WITH THE TWISTED PLUNGER. THE CORRECT LOT NUMBER IS 9016807 (CATALOG 990687). THE INCIDENT WAS NOTICED BEFORE THE USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AN UNSPECIFIED NUMBER OF SYRINGE PLASTIPAK 20ML LL S/SU EXPERIENCED STOPPER DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO NOTIFY 1 BD LUER-LOK 20 ML SYRINGE UNIT, WHICH CAME WITH THE TWISTED PLUNGER. THE CORRECT LOT NUMBER IS 9016807 (CATALOG 990687). THE INCIDENT WAS NOTICED BEFORE THE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015880 SYRINGE PLASTIPAK 20ML LL S/SU SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9016807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other