BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL NEXT GEN 5.4QT RED 20/PACK

    MDR report key: 8785333 · Received July 12, 2019

    Report

    Report Number
    2243072-2019-01405
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 24, 2019
    Report Date
    August 12, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903055178
    PMA / PMN Number
    K943141
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE DHR REVIEW PROCESS WAS NOT A ABLE TO BE PERFORMED DUE TO THE LOT NUMBER WAS UNKNOWN. BD CONFIRMED 5 RETURNED COLLECTOR BOXES HAD NO PRODUCT LABELS. IT WAS CONFIRMED THE LACK OF LABEL FAILURE MODE IS RELATED TO THE MANUFACTURING PROCESS. CONCLUSION: BASED ON THIS INVESTIGATION IT WAS CONFIRMED THIS ISSUE LIKE A FAILURE MODE RELATED TO MANUFACTURING PROCESS, THE CURRENT PROCESS CONTROLS WERE REVIEWED AND IT WAS CONFIRMED THAT THERE ARE FILTERS ALREADY IMPLEMENTED WITHIN THE PROCESS THROUGH VISUAL INSPECTIONS; AS PART OF THE FOLLOWING-UP ON THIS COMPLAINT, A QUALITY ALERT MED-QAJ-C-1917 WAS POSTED IN THE MANUFACTURING PROCESS TO MAKE AWARE ALL PEOPLE INVOLVED IN THE MANUFACTURING OF THIS PRODUCT; ACCORDING TO RISK ASSESSMENT RESULT A CORRECTIVE ACTION IS NOT REQUIRED HOWEVER THE ISSUE WAS CONSIDERED CRITICAL THEREFORE, MISSING LABEL ISSUE WILL BE ADDRESSED TO A CAPA RECORD CAR-JRZ-00000127. ALL THE COMPLAINT INFORMATION WAS CAPTURED ALSO FOR TRACKING AND TRENDING PURPOSES. ROOT CAUSE: THE ROOT CAUSES THAT CONTRIBUTE TO A PART WITHOUT LABEL WERE THE FOLLOWING: LEFT OVER FROM THE LABEL ROLL. LABEL IS DROPPED FROM THE BASE. CHANGE-OVER ROLL. RE-PROCESS METHOD. CONTAMINATION BY LABEL ROLL WASTE. RIBBON BREAKS IN THE JOINS. H3 OTHER TEXT: SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SHARPS COLL NEXT GEN 5.4QT RED 20/PACK HAS EXPERIENCED 5 CASES OF MISSING LABELS BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: "BIOHAZARD" LABEL WASN'T PLACED ON THE CONTAINER.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SHARPS COLL NEXT GEN 5.4QT RED 20/PACK HAS EXPERIENCED 5 CASES OF MISSING LABELS BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: "BIOHAZARD" LABEL WASN'T PLACED ON THE CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579635 SHARPS COLL NEXT GEN 5.4QT RED 20/PACK HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN 50382903055178

    Patients

    Seq Age Sex Outcome Treatment
    1 Other