BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL CHEMO 3GAL YELLOW NEW CAP

    MDR report key: 11729275 · Received April 26, 2021

    Report

    Report Number
    2243072-2021-01258
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 29, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903050765
    PMA / PMN Number
    K943140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/14/2021. H.6. INVESTIGATION: A SAMPLE WAS RECEIVED AND TESTED BY OUR QUALITY TEAM WITH THE CUSTOMER'S COMPLAINT OF DAMAGED LID. THE LID CLEARLY PRESENTED BROKEN HINGES AND THE SUPPLIER WAS CONTACTED FOR ANY INFORMATION THAT WOULD HELP DISCOVER THE ROOT CAUSE OF THIS VERIFIED COMPLAINT. THE PRODUCTION HISTORY OF THIS DEVICE PRESENTED NO QUALITY ISSUES. THE ROOT CAUSE OF THIS FAILURE IS UNKNOWN AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL CHEMO 3GAL YELLOW NEW CAP LID WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DAMAGED LID OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE LID WAS FOUND TO BE DAMAGED UPON ARRIVAL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHARPS COLL CHEMO 3GAL YELLOW NEW CAP LID WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DAMAGED LID OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE LID WAS FOUND TO BE DAMAGED UPON ARRIVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619713 SHARPS COLL CHEMO 3GAL YELLOW NEW CAP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 0227002 00382903050765

    Patients

    Seq Age Sex Outcome Treatment
    1