BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOCK¿ SYRINGE

    MDR report key: 16541953 · Received March 14, 2023

    Report

    Report Number
    9614033-2023-00022
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 23, 2023
    Report Date
    May 16, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY TWO PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, STOPPER POORLY ASSEMBLED IS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2221226, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE INVESTIGATION RESULTS, POSSIBLE ROOT CAUSE IS ASSOCIATED WITH TRANSFER DISC DIALS. REPLACEMENT OF THE DIAL OF THE TRANSFER DISC WILL BE IMPLEMENTED, AND ADD TO THE MONTHLY PREVENTIVE MAINTENANCE ORDER TO CHECK DIALS. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOCK¿ SYRINGE STOPPER WAS MISALIGNED ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "THROUGH THE PRESENT IT IS WISHED TO INFORM THAT A QUALITY PROBLEM WAS DETECTED IN ONE OF THE PRODUCTS THAT IT PROVIDES US FINDING THAT ¿WHEN TAKING THE SYRINGE THEY NOTICED THE STOPPER WAS IN BAD POSITION AND THEREFORE, THEY DID NOT USE IT¿".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOCK¿ SYRINGE STOPPER WAS MISALIGNED ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "THROUGH THE PRESENT IT IS WISHED TO INFORM THAT A QUALITY PROBLEM WAS DETECTED IN ONE OF THE PRODUCTS THAT IT PROVIDES US FINDING THAT ¿WHEN TAKING THE SYRINGE THEY NOTICED THE STOPPER WAS IN BAD POSITION AND THEREFORE, THEY DID NOT USE IT.¿"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444893 BD LUER-LOCK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 2221226

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown