BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT

    MDR report key: 9826691 · Received March 12, 2020

    Report

    Report Number
    2243072-2020-00386
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 25, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ACCORDING TO THE DHR REVIEW PROCESS; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE INCORRECT LIDS DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER REPORTED UNDER THIS CUSTOMER COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE INCORRECT LIDS FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. ACCORDING TO THE PICTURE RECEIVED FROM CUSTOMER, THE INCORRECT LIDS ISSUE WAS CONFIRMED AS A MANUFACTURING PROCESS PROBLEM, PREVIOUS COMPLAINT HAS BEEN RECEIVED, THE MOST RECENT WAS RECEIVED ON 2018, SINCE THIS SUBASSEMBLY IS HANDLING IN A RECYCLABLE BOX WHICH NEEDS TO BE INSPECTED PRIOR TO RE-USE TO ENSURE THAT PREVIOUS LABELS WERE REMOVED; THIS PROBLEM HAD ALREADY BEEN IDENTIFIED WITHIN THE PROCESS, FOR THIS REASON A CAPA RECORD # CA-RJ001869 WAS OPENED TO PERFORM A THOROUGH INVESTIGATION AND TO IMPLEMENT AND DOCUMENT CORRECTIVE ACTIONS TO AVOID IN ORDER MINIMIZE RECURRENCES RELATED TO INCORRECT LIDS FOR PRODUCTS OF 14QTS AND 6GALL FAMILY. ROOT CAUSE DOCUMENTED IN THE CAPA #CA-RJ001869 THE METHOD TO REMOVE AND/OR PLACE THE PRODUCT ID LABEL HAS IMPROVEMENT OPPORTUNITIES. CORRECTIVE ACTION DOCUMENTED IN THE CAPA #CA-RJ001869 . MODIFY RECYCLABLE BOXES 20 PACK (BDX-8990120) & 40 (846-BDX-8990121) PACK ADDING A SQUARE MARK SHOWING WHERE THE BOX LABEL MUST BE PLACED, THIS CHANGE MUST BE IMPLEMENTED THRU AGILE SYSTEM WITH A ECO (ENGINEERING CHANGE ORDER). MODIFY THE MPIS TO REINFORCE THE LABEL REMOVAL PROCESS AND TO INDICATE WHERE THE BOX LABEL MUST BE PLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT EXPERIENCED A DEFORMED/DAMAGED/BROKEN LID/LID LOCK/LID LATCH WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING TEETH ON SHARP CONTAINER.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT EXPERIENCED A DEFORMED/DAMAGED/BROKEN LID/LID LOCK/LID LATCH WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING TEETH ON SHARP CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291129 SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT SHARPS COLLECTOR MMK BECTON DICKINSON 7193941

    Patients

    Seq Age Sex Outcome Treatment
    1 Other