BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 14775234 · Received June 22, 2022

    Report

    Report Number
    3002682307-2022-00172
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 3, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 220319. 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, ONE PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, A MISALIGNMENT BETWEEN THE PACKAGE CUTTINGS AND THE LABEL CONTENT WAS CONFIRMED. BASED ON THE SAMPLE FINDINGS, IT HAS BEEN DETERMINED THAT THIS ISSUE RESULTED WITHIN THE PRIMARY PACKAGING MACHINE. THE MACHINE HAS A CUTTING SYSTEM WHICH CREATES THE VARIOUS PERFORATED STRIPS. A MISALIGNMENT OF THE PAPER REEL RESULTED IN INCORRECTLY PLACED CUTS. THE CUTTING SYSTEM IS PERIODICALLY CHECKED, BUT IN THIS CASE, WE UNDERSTAND THAT SOME DEFECTIVE PACKAGES WERE PRODUCED WITHOUT REJECTION BEFORE THE CHECKING OF THE SYSTEM TOOK PLACE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AS THE VARIABLE DATA WAS STILL LEGIBLE, THIS WOULD NOT BE CONSIDERED A SERIOUS ISSUE. 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 THAT THE BD MICROLANCE¿ 3 NEEDLE LABEL WAS INCORRECTLY POSITIONED AND PARTIALLY CUT OFF, RENDERING SOME OF THE INFORMATION UNREADABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PACKAGING AND LABELS ARE NOT CORRECTLY POSITIONED: SOME LABELS ARE NOT READABLE NOT BIG IMPACT"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE LABEL WAS INCORRECTLY POSITIONED AND PARTIALLY CUT OFF, RENDERING SOME OF THE INFORMATION UNREADABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PACKAGING AND LABELS ARE NOT CORRECTLY POSITIONED: SOME LABELS ARE NOT READABLE NOT BIG IMPACT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623276 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown