BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS

    MDR report key: 12522483 · Received September 23, 2021

    Report

    Report Number
    1213809-2021-00655
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    March 22, 2021
    Report Date
    September 24, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0233244. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 8/20/2020. D.4. MEDICAL DEVICE LOT #: 0167848. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 6/15/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0167848. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0233244. A REVIEW SHOWED INSUFFICIENT SILICONE ISSUE WAS REPORTED DURING THE PRODUCTION. PRODUCT WAS REQUALIFIED PER APPLICABLE ACCEPTABLE QUALITY LIMIT BEFORE PRODUCTION RESUMED. NO SAMPLE WAS RETURNED THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED AND COMPLAINT COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS THERE WAS LEAKAGE. THIS EVENT OCCURRED 604 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE SYRINGE IS NOT SELF-FILLING. SYRINGE LEAKING BLOOD POST DRAW, WHEN PLACING INTO THE SAFETY DEVICE."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 WHEN USING THE BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS THERE WAS LEAKAGE. THIS EVENT OCCURRED 604 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE SYRINGE IS NOT SELF-FILLING. SYRINGE LEAKING BLOOD POST DRAW, WHEN PLACING INTO THE SAFETY DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416930 BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1