BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 3ML LUER-LOK SYRINGE

    MDR report key: 8900899 · Received August 16, 2019

    Report

    Report Number
    3003916417-2019-00400
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 6, 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

    INVESTIGATION SUMMARY: BATCH HISTORY ANALYSIS, QUALITY NOTIFICATIONS AND MAINTENANCE RECORDS WERE REVIEWED WITH NO RECORDS POTENTIALLY RELATED TO FAILURE FOUND. A VIDEO WAS AVAILABLE FOR ANALYSIS, AND IT WAS POSSIBLE TO OBSERVE BARREL DAMAGE THAT LATER DURING THE USE OF THE SYRINGE CAUSED LEAKAGE. THE POSSIBLE CAUSE FOR THIS IS AN ISSUE IN THE SYRINGE ASSEMBLY SYSTEM THAT CAUSED DAMAGE TO THE SYRINGE. THE PRODUCTION PROCESSES ARE VALIDATED ACCORDING TO ESTABLISHED PROCEDURES AND THAT FOR THE PERTINENT CHARACTERISTIC OF THIS COMPLAINT THE ACCEPTANCE CRITERIA ARE NQA 0.4%. THE BATCH INVOLVED IN THE COMPLAINT MEETS THE ACCEPTABLE QUALITY LEVEL (EQS) BEING MANUFACTURED AND RELEASED IN ACCORDANCE WITH APPLICABLE PROCEDURES AND SPECIFICATIONS. THE INCIDENT IDENTIFIED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND ASSESSMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 3ML LUER-LOK¿ SYRINGE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE TIME OF MEDICINE ADMINISTRATION, THE LIQUID GO BACK THROUGH PLUNGER.

    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 BD PLASTIPAK¿ 3 ML LUER-LOK¿ SYRINGE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE TIME OF MEDICINE ADMINISTRATION, THE LIQUID GO BACK THROUGH PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697445 BD PLASTIPAK 3ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 8352734

    Patients

    Seq Age Sex Outcome Treatment
    1 Other