BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE ¿ 3 NEEDLES

    MDR report key: 14720081 · Received June 16, 2022

    Report

    Report Number
    3002682307-2022-00164
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 18, 2022
    Report Date
    May 26, 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

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304622 AND LOT NUMBER 220129. 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, TWO PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, A MICROLANCE SHELF-CARTON WAS OBSERVED WITHOUT THE LABEL; THEREFORE, THE REPORTED DEFECT WAS CONFIRMED. DURING THE PRODUCTION PROCESS, THE LABELS ARE PRINTED AND PLACED WITHIN THE SECONDARY PACKAGING MACHINE. AN AUTOMATED PROCESS PRINTS THE VARIABLE INFORMATION AND STICKS THE LABEL ONTO THE SHELF CARTONS BEFORE INTRODUCTION TO THE SHIPMENT CASES. AN AUTOMATED DETECTION SYSTEM IS IN PLACE TO VERIFY THE CORRECT APPLICATION OF THE LABEL AND REJECT ANY SHELF-CARTONS WHICH ARE MISSING A LABEL. THIS DETECTION SYSTEM IS CHALLENGED EVERY EIGHT WORKING HOURS. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM A TEMPORARY FAILURE IN THE LABEL FEEDER. THE SHELF-CARTONS WERE MOST LIKELY DETECTED AS FAULTY AND SIGNALED FOR REJECTION; HOWEVER, IT IS POSSIBLE THAT THE OPERATOR DID NOT PROPERLY REJECT THE AFFECTED MATERIAL. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. MANUFACTURING PERSONAL HAVE BEEN ALERTED OF THIS EVENT IN ORDER TO RAISE AWARENESS FOR THIS POTENTIAL DEFECT ON THE PRODUCTION FLOOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE ¿ 3 NEEDLES ARE MISSING THE LABELING ON THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LABELING ON THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845860 BD MICROLANCE ¿ 3 NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown