BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE PLASTIPAK 20ML LL S/SU

    MDR report key: 9872403 · Received March 24, 2020

    Report

    Report Number
    3003916417-2020-00096
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    February 21, 2020
    Report Date
    April 17, 2020
    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

    ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-03-30. H.6. INVESTIGATION SUMMARY : A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9326902, QUALITY NOTIFICATION AND MAINTENANCE ANALYSIS AND NO OCCURRENCES POTENTIALLY RELATED TO THE DEFECT WAS OBSERVED. THE SAMPLE SENT BY THE CUSTOMER WAS VERIFIED AND IT WAS POSSIBLE OBSERVE FOREIGN MATTER ¿ DIRT. THIS OCCURRENCE IS RELATED TO A CONTAMINATION DURING PRODUCTION PROCESS CAUSED BY PERSONNEL FAILURE DURING THE PACKAGING LINE CLEARANCE. THE OPERATORS WILL BE NOTIFIED FROM THIS COMPLAINT. THE DEFECT IDENTIFIED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE PLASTIPAK 20ML LL S/SU CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIRTY IN THE SYRINGE LUER. ADDITIONAL INFORMATION: LOT NUMBER: 9326902; MATERIAL NUMBER: 990687. THE INCIDENT WAS NOTICED BEFORE THE USE. ANVISA NOTIFICATION: 2020.03.000455".

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDITIONAL PHONE #: (B)(6). INITIAL REPORTER FACILITY NAME: (B)(6). 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 SYRINGE PLASTIPAK 20ML LL S/SU CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIRTY IN THE SYRINGE LUER. ADDITIONAL INFORMATION: LOT NUMBER: 9326902; MATERIAL NUMBER: (B)(4). THE INCIDENT WAS NOTICED BEFORE THE USE. ANVISA NOTIFICATION: (B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339630 SYRINGE PLASTIPAK 20ML LL S/SU SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9326902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other