BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL NEXT GEN 5.4QT RED 20/PACK

    MDR report key: 8803994 · Received July 18, 2019

    Report

    Report Number
    2243072-2019-01473
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 27, 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 ABLE TO BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. IT WAS CONFIRMED THAT THE CONTAINERS WERE MISSING THE LABEL. IT WAS OBSERVED THAT THERE WERE NOT DIRTY MARKS OR LABEL RESIDUES ON THE CONTAINERS. CONCLUSION: BASED ON THIS INVESTIGATION IT WAS CONFIRMED THIS ISSUE IS 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 (B)(4). 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: 1.LEFT OVER FROM THE LABEL ROLL. 2.LABEL IS DROPPED FROM THE BASE. 3.CHANGE-OVER ROLL. 4.RE-PROCESS METHOD. 5.CONTAMINATION BY LABEL ROLL WASTE. 6.RIBBON BREAKS IN THE JOINS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LABELING ERROR OCCURRED BEFORE USE WITH A SHARPS COLL NEXT GEN 5.4QT RED 20/PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LABELS WEREN'T PLACED ON THE COLLECTORS." 2 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 LABELING ERROR OCCURRED BEFORE USE WITH A SHARPS COLL NEXT GEN 5.4 QT RED 20/PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LABELS WEREN'T PLACED ON THE COLLECTORS." 2 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599292 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