BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 16562363 · Received March 16, 2023

    Report

    Report Number
    3002682307-2023-00063
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    February 27, 2023
    Report Date
    May 15, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 26-APR-2023. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300600 AND BATCH NUMBER 211026. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) UNOPENED SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE NEEDLES WERE ASSEMBLED WITH A DISCARDIT 2ML SYRINGE AND LIQUID WENT THROUGH THE NEEDLE CANNULA NORMALLY WITH NO SIGNS OF OCCLUSION OBSERVED. NEEDLES ARE INSPECTED FOR OCCLUSION AS PART OF THE IN-PROCESS INSPECTION AFTER ASSEMBLY. IN CERTAIN CIRCUMSTANCES, THE DRUG USED CAN BECOME DEPOSITED WITHIN THE CANNULA, CAUSING THE NEEDLE TO BLOCK DUE TO CRYSTALLIZATION. OCCLUSION IS MOST LIKELY TO OCCUR IF THE DRUG REMAINS IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ HYPODERMIC NEEDLE WAS BLOCKED DURING USE AND BLOOD LEAKED OUT WHEN REMOVING IT FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLOOD IS NOT FLOWING EVEN THOUGH IT IS IN THE VEIN, AND TO SHOW THAT IT'S THE NEEDLE, IMMEDIATELY WHEN YOU REMOVE IT FROM THE PATIENT, BLOOD GUSHES OUT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ HYPODERMIC NEEDLE WAS BLOCKED DURING USE AND BLOOD LEAKED OUT WHEN REMOVING IT FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLOOD IS NOT FLOWING EVEN THOUGH IT IS IN THE VEIN, AND TO SHOW THAT IT'S THE NEEDLE, IMMEDIATELY WHEN YOU REMOVE IT FROM THE PATIENT, BLOOD GUSHES OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824776 BD MICROLANCE¿ HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 211026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown