BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE ¿ 3 NEEDLE

    MDR report key: 13192648 · Received January 7, 2022

    Report

    Report Number
    3002682307-2021-00676
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 10, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 210613. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BD RECEIVED A PICTURE OF THE AFFECTED SAMPLE. A NEEDLE WITH BROWN STAINING WAS OBSERVED IN THE EPOXY LOCATION. THE EPOXY IS THE WHITE GLUE USED TO JOIN THE CANNULA AND HUB COMPONENTS. WE UNDERSTAND THE LIQUID USED BY THE CLIENT WAS BROWN AND THAT THERE WAS LEAKAGE IN THE CONNECTION BETWEEN THE CANNULA AND HUB COMPONENTS. WITHOUT THE PHYSICAL SAMPLE FOR FURTHER TESTING, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS CANNOT BE IDENTIFIED FOR THIS REPORTED INCIDENT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE ¿ 3 NEEDLE EXPERIENCED LEAKAGE, AND A HOLE IN THE NEEDLE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INJECTION OF A RADIOPHARMACEUTICAL INTO THE PATIENT, THE TECHNICIAN NOTED THE APPEARANCE OF DROPS AT THE LEVEL OF THE CONNECTION BETWEEN THE PLASTIC BASE OF THE NEEDLE AND THE METAL PART. ALMOST ALL OF THE DRUG WAS LOST IN THIS LEAK (CONFIRMED BY THE ABSENCE OF ACTIVITY DETECTED DURING THE PASSAGE UNDER THE CAMERA IN THE PATIENT (SHOULDERS AT 0.2 KCP / S INSTEAD OF 10 TO 16 USUALLY), AND COMPRESS TO 34.35 KCP / S). THE COMPRESS PLACED UNDER THE NEEDLE ABSORBED ALL THE PRODUCT AND THUS AVOIDED CONTAMINATION OF THE ENVIRONMENT OR THE PATIENT. A NEW SYRINGE HAS BEEN PRESCRIBED AND PREPARED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE ¿ 3 NEEDLE EXPERIENCED LEAKAGE, AND A HOLE IN THE NEEDLE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INJECTION OF A RADIOPHARMACEUTICAL INTO THE PATIENT, THE TECHNICIAN NOTED THE APPEARANCE OF DROPS AT THE LEVEL OF THE CONNECTION BETWEEN THE PLASTIC BASE OF THE NEEDLE AND THE METAL PART. ALMOST ALL OF THE DRUG WAS LOST IN THIS LEAK (CONFIRMED BY THE ABSENCE OF ACTIVITY DETECTED DURING THE PASSAGE UNDER THE CAMERA IN THE PATIENT (SHOULDERS AT 0.2 KCP / S INSTEAD OF 10 TO 16 USUALLY), AND COMPRESS TO 34.35 KCP / S). THE COMPRESS PLACED UNDER THE NEEDLE ABSORBED ALL THE PRODUCT AND THUS AVOIDED CONTAMINATION OF THE ENVIRONMENT OR THE PATIENT. A NEW SYRINGE HAS BEEN PRESCRIBED AND PREPARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991998 BD MICROLANCE ¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210613

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown