BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL AUS 1.4L YELLOW

    MDR report key: 11408352 · Received March 3, 2021

    Report

    Report Number
    2243072-2021-00697
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 5, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: AN INVESTIGATION WAS NOT ABLE TO BE CONDUCTED DUE TO LACK OF INFORMATION PROVIDED SUCH AS PHOTOS OR A PHYSICAL SAMPLE BEING SENT. THE DEVICE HISTORY RECORD REVIEW WAS NOT ABLE TO BE PERFORMED DUE TO AN INACCURATE LOT NUMBER FOR THE MATERIAL IN REFERENCE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL AUS 1.4L YELLOW LID DOES NOT STAY CLOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LID OF SHARPS CONTAINER FLIPS OPEN. THE CUSTOMER HAS DESCRIBED THE LID OF THE CONTAINER DOES NOT STAY CLOSED AND SHE HAS TO TAP IT TO KEEP IT CLOSED. SHE PURCHASED THE CONTAINER ABOUT 6 MONTHS AGO FROM THE PHARMACY AND HAS ONLY JUST NOTICED THE LID NOT STAYING CLOSED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HDQ US (B)(4) . 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 WAS REPORTED THAT SHARPS COLL AUS 1.4L YELLOW LID DOES NOT STAY CLOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LID OF SHARPS CONTAINER FLIPS OPEN. THE CUSTOMER HAS DESCRIBED THE LID OF THE CONTAINER DOES NOT STAY CLOSED AND SHE HAS TO TAP IT TO KEEP IT CLOSED. SHE PURCHASED THE CONTAINER ABOUT 6 MONTHS AGO FROM THE PHARMACY AND HAS ONLY JUST NOTICED THE LID NOT STAYING CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303033 SHARPS COLL AUS 1.4L YELLOW SHARPS CONTAINER MMK BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1