BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 16316256 · Received February 7, 2023

    Report

    Report Number
    3002682307-2023-00016
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    December 27, 2022
    Report Date
    March 22, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 08-FEB-2023. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 220319. 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, ONE (1) SHELF CARTON OF NEEDLE SAMPLES WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. TWENTY (20) SAMPLES WERE SELECTED FOR THOROUGH EXAMINATION. EACH OF THE SAMPLES WAS MICROSCOPICALLY EXAMINED AND NO SIGNS OF CLOGGED NEEDLE WERE OBSERVED. THE NEEDLES WERE THEN ASSEMBLED WITH A 2ML DISCARDIT SYRINGE AND LIQUID WAS FOUND TO MOVE THROUGH THE CANNULA NORMALLY WITH NO SIGNS OF DEFECT. ALTHOUGH WE WERE UNABLE TO REPRODUCE THE REPORTED DEFECT, BASED ON THE PROVIDED FEEDBACK, WE UNDERSTAND THAT AN ISSUE REGARDING A CLOGGED OR PARTIALLY CLOGGED NEEDLE TOOK PLACE. DURING THE CANNULA ASSEMBLY PROCESS, NEEDLES ARE INSPECTED THROUGH USE OF A CAMERA SYSTEM. THE CAMERA SENSES A LIGHT SOURCE POSITIONED ON THE OPPOSITE END OF THE NEEDLE. IF THE CAMERA DOES NOT SENSE THE LIGHT SOURCE, AN OCCLUSION MAY BE PRESENT, AND THE NEEDLE IS AUTOMATICALLY REJECTED. ADDITIONAL INSPECTIONS FOR OCCLUSION ARE ALSO COMPLETED 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.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FAX # PROVIDED: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: NEEDLE DON'T RELEASE LIQUID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: NEEDLE DON'T RELEASE LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309930 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown