BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SHARPS COLL 19L YELLOW

    MDR report key: 15912107 · Received December 3, 2022

    Report

    Report Number
    2243072-2022-02092
    Event Type
    Injury
    Date Received
    December 3, 2022
    Date of Event
    November 8, 2022
    Report Date
    February 28, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 , AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY PHOTOS REPRESENTATION WAS PROVIDED FOR THE COMPLAINT. IT WAS REPORTED BY CUSTOMER THAT A SHARPS BIN PROVIDED HAS FAILED LEADING TO A SHARPS INJURING THAT COULD POTENTIALLY CAUSE DISEASE TRANSMISSION. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL 303209 COULD NOT BE PROVIDED AS THE BATCH NUMBER WAS NOT PROVIDED AND IS UNKNOWN. IT WAS VERIFIED THAT QA PAPERWORK FROM THE PAST 6 MONTHS, THAT ALL 17L YELLOW SHARPS CONTAINERS ARE WELL WITHIN SPECIFICATION ON WALL THICKNESS. AS THIS RAISED ISSUE IS NOT PRODUCT RELATED, A POTENTIAL ROOT CAUSE FOR PIERCING THE SHARPS CONTAINER WALL COULD BE - EXCESSIVE FORCE USED TO PLACE THE SHARPS INTO THE CONTAINER ABOVE THE RECOMMENDED FILL LINE THE CONTAINER GOT PIERCED THROUGH ONE OF THE THICKEST WALL PART OF THE CONTAINER ABOVE THE RECOMMENDED MAXIMUM FILLING LINE BY BD. THE MAXIMUM FILL LINE IS FOR EACH CONTAINER AND IS HIGHLIGHTED ON THE BD LABEL, THAT IS PROVIDED TO US BY BD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SHARPS COLL 19L YELLOW SHARPS PROTRUDED THROUGH THE WALL AND LED TO A NEEDLESTICK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A SHARPS BIN HAS FAILED LEADING TO A SHARPS INJURING THAT COULD POTENTIALLY CAUSE DISEASE TRANSMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SHARPS COLL 19L YELLOW SHARPS PROTRUDED THROUGH THE WALL AND LED TO A NEEDLESTICK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A SHARPS BIN HAS FAILED LEADING TO A SHARPS INJURING THAT COULD POTENTIALLY CAUSE DISEASE TRANSMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946040 BD SHARPS COLL 19L YELLOW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention