BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL CANADA 3.0L YELLOW

    MDR report key: 11657474 · Received April 13, 2021

    Report

    Report Number
    2243072-2021-01105
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 16, 2021
    Report Date
    June 26, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTO OR SAMPLE REPRESENTATION WAS PROVIDED FOR THE COMPLAINT. A DHR REVIEW WAS PERFORMED AND SHOWED THERE WERE NO ISSUES REPORTED LIKE ASSEMBLY DIFFICULT DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER 9262917. A REVIEW OF NON-CONFORMING MATERIAL REPORT (NCMR) WAS PERFORMED FOR THIS PART FOR THE PAST 12 MONTHS AND NO ISSUES WERE REPORTED FOR ASSEMBLY DIFFICULT FOR THE SAME PART NUMBER. ACCORDING TO THIS INVESTIGATION THERE IS NOT ENOUGH INFORMATION TO DETERMINE ANY ROOT CAUSE FOR THE FAILURE. TO RULE OUT MISUSE, A PHOTO AND OR SAMPLE OF THE EFFECTED PRODUCT IS NECESSARY. ROOT CAUSE UNKNOWN. BD WILL CONTINUE TO MONITOR FOR ANY TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHARPS COLL CANADA 3.0L YELLOW CONTAINER LID WAS DAMAGED AND KEPT FALLING OFF. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED LID KEEPS FALLING OFF/OUT OF CONTAINER".

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4), NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: NA. 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 THE SHARPS COLL CANADA 3.0L YELLOW CONTAINER LID WAS DAMAGED AND KEPT FALLING OFF. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED LID KEEPS FALLING OFF/OUT OF CONTAINER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556566 SHARPS COLL CANADA 3.0L YELLOW SHARPS CONTAINER FMI BECTON DICKINSON 9262917

    Patients

    Seq Age Sex Outcome Treatment
    1