BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15953510 · Received December 9, 2022

    Report

    Report Number
    9614033-2022-00108
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 16, 2022
    Report Date
    January 5, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMI
    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

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: FOUR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, PRIMARY PACKAGING CAN BE SEEN AND A SYRINGE WITH A NEEDLE ASSEMBLED ON ONE OF THE SIDES IS DISPLAYED. UNABLE TO CONFIRM FAILURE REPORTED FROM THE IMAGES, PHYSICAL SAMPLES ARE NECESSARY TO FURTHER ANALYZE AND CONDUCT A THOROUGH INVESTIGATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 07-DEC-2022. H6: INVESTIGATION SUMMARY FOUR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, PRIMARY PACKAGING CAN BE SEEN AND A SYRINGE WITH A NEEDLE ASSEMBLED ON ONE OF THE SIDES IS DISPLAYED. UNABLE TO CONFIRM FAILURE REPORTED FROM THE IMAGES. ADDITIONALLY, TWO SYRINGE SAMPLES RECEIVED, THE HUB HAS SLIGHT SUPERFICIAL MARKS WHICH ARE PART OF THE PROCESS OF MOLDING THE HUB, IT DOES NOT AFFECT ITS FUNCTIONALITY. LEAK TEST WAS PERFORMED, NO LEAKAGE OBSERVED, NO OTHER DEFECTS OR ISSUES OBSERVED. ADEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL. EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IN THE ALLEGED BATCH IT WAS FOUND ONE SYRINGE THAT HAS A LEAKAGE IN NEEDLE PART, WHICH WAS DETECTED AT THE MOMENT OF DRUG ASPIRATION. THE CUSTOMER DECIDED TO DON'T USE THE REST OF SYRINGES AND COMPLETE ITS TREATMENT BY REPLACING THEM. LEAKAGE AT LUER CONNECTION FOR UNKNOWN BATCH (MAY BE 1159655 OR 9048600);

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL. EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: IN THE ALLEGED BATCH IT WAS FOUND ONE SYRINGE THAT HAS A LEAKAGE IN NEEDLE PART, WHICH WAS DETECTED AT THE MOMENT OF DRUG ASPIRATION. THE CUSTOMER DECIDED TO DON'T USE THE REST OF SYRINGES AND COMPLETE ITS TREATMENT BY REPLACING THEM. LEAKAGE AT LUER CONNECTION FOR UNKNOWN BATCH (MAY BE 1159655 OR 9048600).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2524813 BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL. HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON DE MEXICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown