BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 11781025 · Received May 5, 2021

    Report

    Report Number
    1911916-2021-00408
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    February 16, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THE BAR CODE IS FAINT IN SOME AREAS. TO AID IN THE INVESTIGATION, THREE SEALED SHELF BOXES AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND NO DAMAGES ARE OBSERVED TO THE SHELF BOXES. THE TWO BARCODE LABELS ON EACH BOX LOOK ACCEPTABLE. EACH BOX LABEL WAS SCANNED AT THE PRODUCTION LINE AND PASSED. ONE PHOTO PROVIDED SHOWS A CASE BOX LABEL AND THE OTHER TWO PHOTOS EACH SHOW A SHELF BOX LABEL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305109, LOT NUMBER 0111042. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE AND PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. PROBABLE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 BD PRECISIONGLIDE¿ NEEDLE S EXPERIENCED A "DEFECTIVE" LABELED PRODUCT THAT WAS SENT TO THE CUSTOMER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305109, BATCH NO: 0111042. THE BAR CODE IS FAINT IN SOME AREAS CAUSING ISSUES WITH RECEIVING AT SOME CUSTOMER LOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674947 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0111042

    Patients

    Seq Age Sex Outcome Treatment
    1