BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 12364977 · Received August 25, 2021

    Report

    Report Number
    3002682307-2021-00430
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    June 29, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 210521 AND 210525. 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, A PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, TWO OUT OF THIRTY-SEVEN SHELF CARTONS SHOWED NO LABEL. THE SHELF CARTON LABELS ARE PRINTED AND PLACED IN THE SECONDARY PACKAGING MACHINE. THE VARIABLE INFORMATION IS PRINTED ON THE LABEL AND THEN STUCK ONTO THE SHELF CARTON BEFORE BEING INTRODUCED INTO THE SHIPPING CASE; ALL OF THESE STEPS ARE DONE AUTOMATICALLY. AN AUTOMATIC DETECTION SYSTEM INSPECTS THE PACKAGING AND REJECTS SHELF CARTONS WITH MISSING LABELS. THIS DETECTION SYSTEM IS CHALLENGED EVERY EIGHT WORKING HOURS. IT HAS BEEN DETERMINED THAT THIS ISSUE MOST LIKELY RESULTED FROM A TEMPORARY FAILURE IN THE LABEL FEEDER CAUSING THE SHELF CARTON TO NOT HAVE A LABEL PLACED. THE SHELF CARTON MOST LIKELY WAS REJECTED BY THE DETECTION SYSTEM, BUT THE OPERATOR DID NOT PROPERLY SEGREGATE THE AFFECTED MATERIAL. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 39 BD MICROLANCE¿ NEEDLES FROM LOT 210521, AND 1 NEEDLE FROM LOT 210525 HAD NO LABELS ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MISSING LABELS."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 210521, MEDICAL DEVICE EXPIRATION DATE: 2026-04-30, DEVICE MANUFACTURE DATE: 2021-05-13. MEDICAL DEVICE LOT #: 210525, MEDICAL DEVICE EXPIRATION DATE: 2026-04-30 , DEVICE MANUFACTURE DATE: 2021-05-13. 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 · 1

    IT WAS REPORTED THAT 39 BD MICROLANCE¿ NEEDLES FROM LOT 210521, AND 1 NEEDLE FROM LOT 210525 HAD NO LABELS ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MISSING LABELS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265083 BD MICROLANCE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown