BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ STAINLESS STEEL NEEDLES

    MDR report key: 13874010 · Received March 24, 2022

    Report

    Report Number
    3002682307-2022-00098
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 2, 2022
    Report Date
    May 17, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 29MAR-2022 H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 211019. 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, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLE SHOWED A LACK OF EPOXY (THE ADHESIVE USED TO JOIN THE CANNULA AND THE HUB COMPONENTS), WHICH WOULD CAUSE THE CANNULA TO BECOME SEPARATED FROM THE HUB. IN THE PICTURES PROVIDED, A DROP OF EPOXY IS OBSERVED ON THE LATERAL PART OF THE HUB. THIS SHOWS THAT THE CANNULA WAS NOT PROPERLY ATTACHED TO THE HUB BECAUSE THE EPOXY WAS NOT DOSED TO THE CORRECT LOCATION DURING THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿ STAINLESS STEEL NEEDLES THE NEEDLE PULLED FREE FROM THE HUB AND EPOXY WAS FOUND ON THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN CONNECTION WITH THE 1ST STITCH WITH THE AFFECTED NEEDLE, THE NEEDLE DETACHES FROM THE PLASTIC CONE. IT LOOSENS WHEN THE CANNULA IS PULLED OUT AFTER INJECTION. THE NEEDLE REMAINS IN THE PATIENT'S OCCIPUT. NEEDLE PROTRUDING FROM THE AREA COULD THEN BE REMOVED WITH THE FINGERS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿ STAINLESS STEEL NEEDLES THE NEEDLE PULLED FREE FROM THE HUB AND EPOXY WAS FOUND ON THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN CONNECTION WITH THE 1ST STITCH WITH THE AFFECTED NEEDLE, THE NEEDLE DETACHES FROM THE PLASTIC CONE. IT LOOSENS WHEN THE CANNULA IS PULLED OUT AFTER INJECTION. THE NEEDLE REMAINS IN THE PATIENT'S OCCIPUT. NEEDLE PROTRUDING FROM THE AREA COULD THEN BE REMOVED WITH THE FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864241 BD MICROLANCE¿ STAINLESS STEEL NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 211019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown