BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE ¿ 3 NEEDLE

    MDR report key: 15749416 · Received November 7, 2022

    Report

    Report Number
    3002682307-2022-00298
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    October 13, 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
    NL
    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: 09-NOV-2022 H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 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, ONE PICTURE SAMPLE, ONE UNPACKAGED NEEDLE, ONE SHELF CARTON OF 100 PACKAGED NEEDLES, AND ONE SHELF CARTON OF 45 PACKAGED NEEDLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, NO ISSUES WERE DETECTED WITH THE PACKAGED NEEDLES. THE UNPACKAGED NEEDLE SHOWED AN EXTRANEOUS CANNULA STUCK ONTO THE HUB COMPONENT WITH RESIDUAL EPOXY (THE ADHESIVE USED TO JOIN THE CANNULA AND HUB COMPONENTS). 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 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. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. H3 OTHER TEXT : SEE H10

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE ¿ 3 NEEDLE EXPERIENCED THE NEEDLE POINT PENETRATING THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJECTION NEEDLE WITH THE NEEDLE STICKING OUT OF THE PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE ¿ 3 NEEDLE EXPERIENCED THE NEEDLE POINT PENETRATING THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJECTION NEEDLE WITH THE NEEDLE STICKING OUT OF THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376316 BD MICROLANCE ¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210828

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown