BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 15033960 · Received July 15, 2022

    Report

    Report Number
    3002682307-2022-00185
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 16, 2022
    Report Date
    July 19, 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 210335. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED NEEDLE SAMPLES FROM THE REPORTED LOT NUMBER WERE OBTAINED FOR EVALUATION. THE RETAINED NEEDLE SAMPLES WERE ASSEMBLED WITH A CAVERJECT SYRINGE BY FOLLOWING THE INSTRUCTIONS; THE NEEDLE HUB WAS POSITIONED ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NONE OF THE RETAINED NEEDLES PRESENTED ANY SIGN OF DEFECT; THE HUBS FIT PERFECTLY ONTO THE SYRINGE TIP. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO IDENTIFY A MANUFACTURING RELATED CAUSE FOR THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE EXPERIENCED SEPARATION BETWEEN THE NEEDLE AND SYRINGE RESULTING IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WEEK WHEN HE WENT TO PERFORM THE APPLICATION, THE NEEDLE CAME OUT OF THE SYRINGE AND LOST ALL THE LIQUID. HE REPORTED THAT THE NEEDLE DID NOT LOCK VERY WELL INTO THE SYRINGE, "THE NEEDLE IS TOO THIN AND SMALL". THE NEEDLE CAME OUT OF THE SYRINGE AND GOT STUCK IN HIS MALE GENITAL ORGAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE EXPERIENCED SEPARATION BETWEEN THE NEEDLE AND SYRINGE RESULTING IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WEEK WHEN HE WENT TO PERFORM THE APPLICATION, THE NEEDLE CAME OUT OF THE SYRINGE AND LOST ALL THE LIQUID. HE REPORTED THAT THE NEEDLE DID NOT LOCK VERY WELL INTO THE SYRINGE, "THE NEEDLE IS TOO THIN AND SMALL". THE NEEDLE CAME OUT OF THE SYRINGE AND GOT STUCK IN HIS MALE GENITAL ORGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2883914 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210335

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown