BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL CHEMO 9GAL YELLOW

    MDR report key: 12038050 · Received June 21, 2021

    Report

    Report Number
    2243072-2021-01721
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 7, 2021
    Report Date
    September 29, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903056033
    PMA / PMN Number
    K943140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A COMPLAINT WAS RECEIVED REGARDING MISSING LID(S) AND INVESTIGATION WAS COMPLETED WITH THE INFORMATION PROVIDED. ACCORDING TO THE DHR REVIEW PROCESS, THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS DURING THE MANUFACTURING PROCESS FOR THE LOT 1102927 REPORTED, ADDITIONALLY, A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS ISSUE FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. BASED ON INFORMATION PROVIDED IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE LIKE A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS BECAUSE THERE IS NOT ENOUGH INFORMATION LIKE METHOD USED TO HANDLE, SHIPPED PARTIAL SELLS AND CONTROLS TO STORAGE THE REMAINING PRODUCT WITHIN DISTRIBUTOR FACILITY. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL CHEMO 9GAL YELLOW WAS MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER RECEIVED 1 CASE OF CONTAINERS WITHOUT LIDS.

    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 IN 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 9GAL YELLOW WAS MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER RECEIVED 1 CASE OF CONTAINERS WITHOUT LIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933892 SHARPS COLL CHEMO 9GAL YELLOW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305603 1102927 00382903056033

    Patients

    Seq Age Sex Outcome Treatment
    1