BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿3 NEEDLES

    MDR report key: 15033924 · Received July 15, 2022

    Report

    Report Number
    3002682307-2022-00183
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 15, 2022
    Report Date
    July 5, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301500 AND LOT NUMBER 210923. 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, PICTURE SAMPLES AND THE PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, A SHELF CARTON WITHOUT A LABEL WAS OBSERVED. THE LABELS ARE PRINTED AND PLACED WITHIN THE SECONDARY PACKAGING MACHINE BY AN AUTOMATED PROCESS. THERE IS AN AUTOMATIC DETECTION SYSTEM IN PLACE TO VERIFY THAT ALL SHELF CARTONS CONTAIN THE PROPER LABELING. THIS DETECTION SYSTEM IS CHALLENGED EVERY EIGHT WORKING HOURS. WE BELIEVE THAT THIS INCIDENT RESULTED FROM A TEMPORARY FAILURE IN THE LABEL FEEDER AND THEN IMPROPER REJECTION OF THE DEFECTIVE MATERIAL BY THE OPERATOR ONCE IT WAS DETECTED BY THE AUTOMATED SYSTEM. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿3 NEEDLES THE LABEL WAS MISSING DETAILS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD MICROLANCE 3 WITH NO REFERENCE,LOT OR EXPIRY DETAILS PRINTED ON THE SECONDARY PACKAGING. IMPORTANT DETAILS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2890165 BD MICROLANCE¿3 NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210923

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown