BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 15635489 · Received October 19, 2022

    Report

    Report Number
    3002682307-2022-00279
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 22, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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-NOV-2022 . H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 210403 AND 210828. 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 THESE ISSUES, THE PHYSICAL SAMPLES OF THE AFFECTED BATCHES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, AN EXTRANEOUS CANNULA WAS OBSERVED AS WELL AS FOREIGN MATTER (BLACK SPOTS). THE EXTRA CANNULA WAS PRODUCED DURING THE ASSEMBLY PROCESS, WHERE THE INSERTION OF THE CANNULA INTO THE HUB TAKES PLACE THROUGH THE USE OF A ROTARY FEEDER. AS A RESULT OF SOME ISOLATED ISSUE, A CANNULA BECAME DETACHED AND FELL ONTO THE AFFECTED PRODUCT. ONCE THE ADHESIVE USED TO JOIN THE CANNULA TO THE HUB WAS CURED IN THE OVEN SYSTEM, THE EXTRANEOUS CANNULA REMAINED STUCK. THIS TYPE OF SITUATION IS MORE LIKELY TO OCCUR IN SMALLER GAUGE NEEDLES DUE TO THEIR LOW WEIGHT. IT HAS BEEN CONCLUDED THAT THE BLACK SPOTS RESULTED FROM RESIDUE OR AN AUXILIAR COMPONENT WITHIN THE PACKAGING MACHINERY. ANY ACTIVITY PERFORMED WITHIN THE PACKAGING MACHINE FOLLOWS PREVENTIVE MEASURES DEFINED IN OUR PROCEDURES. ALTHOUGH THE HIGH-VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, BD KEEPS THE PARTICULATE MATTER TO EXTREMELY LOW LEVELS DUE TO THE STRINGENT PREVENTIVE MEASURES IN PLACE. THE ENTIRE ASSEMBLY AND PACKAGING PROCESS TAKES PLACE IN AN ENVIRONMENTAL CONTROLLED ROOM WHERE GOOD MANUFACTURING PRACTICES ARE FOLLOWED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: INITIAL REPORTER PHONE #: (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 EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT CONTAMINATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046106 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210828

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown