BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

    MDR report key: 19047525 · Received April 4, 2024

    Report

    Report Number
    9614033-2024-00036
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 18, 2024
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903002566
    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. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PHOTOS AND VIDEO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, ANTS CAN BE SEEN INSIDE THE PACKAGING OF THE PRODUCT, THEREFORE THE INCIDENT IS CONFIRMED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 3233186 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. STERILIZATION TESTING WAS PERFORMED AND RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. ADDITIONALLY, BD PRODUCTS ARE STERILIZED WITH ETHYLENE OXIDE, WHICH IS A PROCESS THAT GUARANTEES THE ELIMINATION OF ANY BIOLOGICAL CONTAMINATION, SO IF CONTAMINATION OCCURS DURING THE MANUFACTURING AND PACKAGING OF THE PRODUCT, IN THE STERILIZATION PROCESS ANY ORGANISM PRESENT WOULD NOT HAVE SURVIVED. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    PHOTOS AND VIDEO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, ANTS CAN BE SEEN INSIDE THE PACKAGING OF THE PRODUCT, THEREFORE THE INCIDENT IS CONFIRMED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 3233186 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. CONTROLS FOR PEST MITIGATION AT THE BD PLANT AND DISTRIBUTION CENTER ARE COMPLIANT. ADDITIONALLY, BD PRODUCTS ARE STERILIZED WITH ETHYLENE OXIDE, WHICH IS A PROCESS THAT GUARANTEES THE ELIMINATION OF ANY BIOLOGICAL CONTAMINATION, SO IF CONTAMINATION OCCURS DURING THE MANUFACTURING AND PACKAGING OF THE PRODUCT, IN THE STERILIZATION PROCESS ANY ORGANISM PRESENT WOULD NOT HAVE SURVIVED. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: PER TWITTER VIDEO, ANTS CAN BE SEEN IN A SEALED BD SYRINGE. WHAT HAPPENED TO THE QUALITY CONTROL OF BECTON DICKINSON S.A DE C.V.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334730 BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL SYRINGE FMF BECTON DICKINSON DE MEXICO 3233186 00382903002566

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown