BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 11586906 · Received March 29, 2021

    Report

    Report Number
    3003152976-2021-00175
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/5/2021. H.6. INVESTIGATION: ONE PHOTO AND ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A HAIR CAN BE OBSERVED AROUND THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2010059, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT IS LIKELY DUE TO PERSONNEL NOT FOLLOWING PROPER GOWNING PROCEDURES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL HAD FOREIGN MATTER INSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PREPARATION OF DRUGS, A HAIR THAT WAS STUCK INSIDE THE SYRINGE WAS DISCOVERED.

    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 SYRINGE 50ML LL HAD FOREIGN MATTER INSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PREPARATION OF DRUGS, A HAIR THAT WAS STUCK INSIDE THE SYRINGE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481846 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2010059

    Patients

    Seq Age Sex Outcome Treatment
    1