BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE PLASTIPAK 20ML LL S/SU

    MDR report key: 9856528 · Received March 19, 2020

    Report

    Report Number
    3003916417-2020-00091
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 31, 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

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 990687, 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 TO OBSERVE SCALE MARKING ISSUE. THE PROBABLE CAUSE FOR THE OCCURRENCE IS RELATED TO FAILURE AT PRINTING SYSTEM AT THE MARKING MACHINE, ALLOWING THE DEFECT PRODUCT FLOW OF THE PROCESS. THE INCIDENT IDENTIFIED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND EVALUATION. H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: D.4. MEDICAL DEVICE LOT #: 9235062; D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31; H.4. DEVICE MANUFACTURE DATE: 2019-08-23 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES PLASTIPAK 20ML LL S/SU EXPERIENCED MISSING SCALE MARKING. THE PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRADUATION OF THE ERASED SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES PLASTIPAK 20ML LL S/SU EXPERIENCED MISSING SCALE MARKING. THE PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRADUATION OF THE ERASED SYRINGE.

    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 SYRINGES PLASTIPAK 20ML LL S/SU EXPERIENCED MISSING SCALE MARKING. THE PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRADUATION OF THE ERASED SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321530 SYRINGE PLASTIPAK 20ML LL S/SU SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9235062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other