BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 11L NEXT GEN YELLOW AU

    MDR report key: 11341027 · Received February 17, 2021

    Report

    Report Number
    2243072-2021-00346
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 21, 2021
    Report Date
    March 2, 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

    INVESTIGATION SUMMARY: A PHOTO BUT NO SAMPLE REPRESENTATION WAS PROVIDED FOR THE COMPLAINT. A DHR REVIEW WAS PERFORMED AND SHOWED THERE WERE NO ISSUES REPORTED LIKE LABELING CONCERNS DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER 0130935. A REVIEW OF NON-CONFORMING MATERIAL REPORT (NCMR) WAS PERFORMED FOR THIS PART FOR THE PAST 12 MONTHS AND NO ISSUES WERE REPORTED FOR LABELING CONCERNS FOR THE SAME PART NUMBER. ACCORDING TO THIS INVESTIGATION THIS IS A KNOWN FAILURE MODE RELATED TO A MANUFACTURING PROCESS BECAUSE IT WAS REPORTED IN PREVIOUS COMPLAINTS RECORD (B)(4), DUE TO THIS COMPLAINTS A CAPA RECORD (B)(4). WAS OPENED TO IMPLEMENT A SOFTWARE UPDATE TO MITIGATE ANY ERRORS OR DUPLICATES IN THE BASE LABELS, THE SOFTWARE WAS IMPLEMENTED ON (B)(6) 2020, HOWEVER, BASED IN THE MANUFACTURING DATE OF THE LOT NUMBER (0130935) REPORTED IN THE COMPLAINT IT WAS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED BEFORE A CORRECTIVE ACTIONS IMPLEMENTATION. ROOT CAUSE FOUND TO BE AN OMISSION ERROR (BEFORE THE CORRECTIVE ACTION IMPLEMENTATION THE IN-HOUSE PRINTING PROCESS WAS BEING PERFORMED THROUGH MANUAL INPUTS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL 11L NEXT GEN YELLOW AU HAD INCORRECT LABEL INFORMATION ON 8 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 5.1LL LABEL 301272 PLACED ON 11.3 L CONTAINER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHARPS COLL 11L NEXT GEN YELLOW AU HAD INCORRECT LABEL INFORMATION ON 8 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 5.1LL LABEL 301272 PLACED ON 11.3 L CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236415 SHARPS COLL 11L NEXT GEN YELLOW AU SHARPS CONTAINER MMK BECTON DICKINSON 0130935

    Patients

    Seq Age Sex Outcome Treatment
    1