BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE

    MDR report key: 17009070 · Received May 26, 2023

    Report

    Report Number
    9614033-2023-00036
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    February 27, 2023
    Report Date
    June 1, 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

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6. INVESTIGATION SUMMARY: PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, IN THIS FIRST IMAGE, A BOX WITH ITS IDENTIFICATION LABEL WHERE IT IS POSSIBLE TO CORROBORATE THE LOT NUMBER (2251340) IS OBSERVED. SECOND IMAGE, LATERAL SIDE OF THE BOXES ARE DISPLAYED, LABEL IS NOT PLACED ON THE SIDE SHOWN IN THE PICTURE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. ON THE FRONT OF THE BOX, THERE IS A DELIMITED AREA TO PLACE THE LABEL, PHYSICAL SAMPLES ARE REQUIRED TO FURTHER ANALYZE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 9614033-2023-00036 WAS SENT IN ERROR. (GENERAL DISSATISFACTION) IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION. MFR#: 9614033-2023-00036 IS VOID AS A RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BOX OF BD¿ SYRINGES HAD NO LABEL ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "IT IS REPORTED THAT A QUALITY PROBLEM WAS DETECTED IN ONE OF THE PRODUCTS PROVIDED BY ¿THE WAREHOUSE STAFF IS NOTICED, WHICH, IN THE CORRUGATED 4 BOXES, 3 CAME WITH A LABEL AND A BOX OF 100 PIECES DID NOT CONTAIN THE CORRESPONDING LABEL¿"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BOX OF BD¿ SYRINGES HAD NO LABEL ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "IT IS REPORTED THAT A QUALITY PROBLEM WAS DETECTED IN ONE OF THE PRODUCTS PROVIDED BY ¿THE WAREHOUSE STAFF IS NOTICED, WHICH, IN THE CORRUGATED 4 BOXES, 3 CAME WITH A LABEL AND A BOX OF 100 PIECES DID NOT CONTAIN THE CORRESPONDING LABEL¿"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915100 BD¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 2251340

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown