BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿

    MDR report key: 13317768 · Received January 21, 2022

    Report

    Report Number
    3003152976-2022-00009
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    December 30, 2021
    Report Date
    March 11, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1912272 . MEDICAL DEVICE EXPIRATION DATE: 2024-11-30. DEVICE MANUFACTURE DATE: 2019-12-12. MEDICAL DEVICE LOT #: 2002219. MEDICAL DEVICE EXPIRATION DATE: 2025-01-31. DEVICE MANUFACTURE DATE: 2020-02-06. MEDICAL DEVICE LOT #: 2002300. MEDICAL DEVICE EXPIRATION DATE: 2025-01-31. DEVICE MANUFACTURE DATE: 2020-02-27. MEDICAL DEVICE LOT #: 2002251. MEDICAL DEVICE EXPIRATION DATE: 2025-01-31. DEVICE MANUFACTURE DATE: 2020-02-14.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT NUMBERS 1912272, 2002219, 2002300 AND 2002251 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. DURING THE BARREL PRINTING PROCESS, OPERATORS CHECK PERIODICALLY THE VOLUME ACCURACY WITH A FREQUENCY OF 10 SAMPLES ONCE A DAY. NO ISSUES WERE IDENTIFIED RELATED TO THE FAILURE REPORTED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PLASTIPAK¿ 20ML SYRINGES LUER-LOK¿ EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE GRADUATION IS NOT CORRECT. THE PROBLEM WAS DETECTED WHEN LOADING VIALS OF ACYCLOVIR. WHEN A 20 ML VOLUME OF ACYCLOVIR WAS LOADED, FIRST WITH 2 10 ML SYRINGES AND THEN WITH 50 ML SYRINGES, THE ENTIRE VIAL WAS LOADED. ON THE CONTRARY WHEN LOADING WITH 20 ML SYRINGES, THERE IS REMAINING VOLUME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PLASTIPAK¿ 20ML SYRINGES LUER-LOK¿ EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE GRADUATION IS NOT CORRECT. THE PROBLEM WAS DETECTED WHEN LOADING VIALS OF ACYCLOVIR. WHEN A 20 ML VOLUME OF ACYCLOVIR WAS LOADED, FIRST WITH 2 10 ML SYRINGES AND THEN WITH 50 ML SYRINGES, THE ENTIRE VIAL WAS LOADED. ON THE CONTRARY WHEN LOADING WITH 20 ML SYRINGES, THERE IS REMAINING VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507106 BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿ PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown