BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SHARPS COLLECTOR

    MDR report key: 17144446 · Received June 16, 2023

    Report

    Report Number
    2243072-2023-01035
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    April 20, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903056132
    PMA / PMN Number
    K943140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE MDR 2243072-2023-01035 IS A DUPLICATE OF 2243072-2023-00783 THIS SUPPLEMENTAL IS TO CANCEL MDR 2243072-2023-01035.

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE AVAILABLE. IT WAS REPORTED BY CUSTOMER THAT " THEY HAVE PROBLEMS WITH THE LIDS" WAS NOT VERIFIED AS NO SAMPLE AVAILABLE. DEVICE HISTORY RECORD REVIEW PROCESS TO VERIFY IF THERE WERE ISSUES REPORTED AS MISSING LIDS OR LID WILL NOT SHUT ISSUE DURING THE MANUFACTURING PROCESS OF THIS PRODUCT WAS NOT ABLE TO BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. A REVIEW OF NON-CONFORMANCE MATERIAL REPORT WAS PERFORMED; THE RESULTS EXHIBIT NO ISSUES REPORTED FOR THE SAME PART NUMBER AND ISSUES THROUGHOUT THE LAST TWELVE MONTHS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ SHARPS COLLECTORS LIDS HAD PROBLEMS CLOSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM OUR CREWS ARE HAVING PROBLEMS PUTTING ON THE SLIDING LIDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ SHARPS COLLECTORS LIDS HAD PROBLEMS CLOSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: OUR CREWS ARE HAVING PROBLEMS PUTTING ON THE SLIDING LIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463065 BD¿ SHARPS COLLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305613 UNKNOWN 00382903056132

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown