BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALPAK 5ML COLS ADAP16 BLS

    MDR report key: 9824759 · Received March 12, 2020

    Report

    Report Number
    3003916417-2020-00081
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 21, 2020
    Report Date
    April 29, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    KYX
    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: THE BATCH HISTORY ANALYSIS WAS PERFORMED, QUALITY NOTIFICATIONS WERE VERIFIED, MAINTENANCE RECORDS AND NO DEVIATION WAS FOUND FOR THIS LOT. IMAGE OF REPORTED INCIDENT WAS RECEIVED FOR ANALYSIS. AT IMAGE IT WAS POSSIBLE OBSERVE 2 SAMPLES WITH FM ¿ BURN PLASTIC AND 1 SAMPLE WITH MISSING ADAPTER. THE DEFECT WAS FOUND IN THE PLUNGER ROD COMPONENT THAT PRESENTED DEGRADED MATERIAL AND IS RELATED TO BURN RESIN INSIDE THE INJECTION CYLINDER OF THE PRESS. THE MISSING ADAPTER CAN BE RELATED TO FAILURE AT FEEDING SYSTEM DURING PACKAGING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ORALPAK 5ML COLS ADAP16 BLS WAS MISSING THE ADAPTER AND THE SYRINGE WAS DIRTY. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PRODUCT PACKAGING PROCESS, SYRINGES WITH DEVIATIONS (MISSING ADAPTER AND DIRTY SYRINGES) WERE FOUND. THE PRODUCTS ARE SEALED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ORALPAK 5ML COLS ADAP16 BLS WAS MISSING THE ADAPTER AND THE SYRINGE WAS DIRTY. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PRODUCT PACKAGING PROCESS, SYRINGES WITH DEVIATIONS (MISSING ADAPTER AND DIRTY SYRINGES) WERE FOUND. THE PRODUCTS ARE SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290916 ORALPAK 5ML COLS ADAP16 BLS ORALPAK KYX BECTON DICKINSON IND. CIRURGICAS LTDA 8178540

    Patients

    Seq Age Sex Outcome Treatment
    1 Other