BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE NS 27GA 3/4IN W/O SIL

    MDR report key: 15451479 · Received September 19, 2022

    Report

    Report Number
    1911916-2022-00502
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 24, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, (B)(6) WAS USED AS A PLACE HOLDER. INVESTIGATION SUMMARY: IT WAS REPORTED ONE OUT OF THE TWO BAGS RECEIVED WITH THIS BATCH WAS MISSING THE BAG LABEL. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW ONE BAG WITH BULK PACKAGED PRODUCT. IT WAS NOT POSSIBLE TO SEE THE BAG LABEL IN ANY OF THE PHOTOS. THIS DEFECT COULD OCCUR IF AN ASSOCIATE OF THE PACKAGING PROCESS MISSED ADDING THE LABEL TO THE BAG. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301671, LOT NUMBER 1082740. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE PRODUCTION LINE FOR THE PACKAGING PROCESS WAS PERFORMED AND THE BAGS WERE BEING PROPERLY LABELED. ASSOCIATES WERE INFORMED ABOUT THE MISSING LABEL. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING THE BD NEEDLE NS 27GA 3/4IN W/O SIL, THE LABEL WAS MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALCON QC TECHNICIAN IDENTIFIED ONE (1) OUT OF THE TWO (2) BAGS RECEIVED WITH THIS BATCH MISSING THE BAG LABEL. QC INCOMING CONFIRMED THAT ONLY ONE BAG FROM THE ENTIRE BATCH HAD A MISSING LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124895 BD NEEDLE NS 27GA 3/4IN W/O SIL HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 1082740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown