BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL SLIDE CLOSE 9 GAL RED KIT

    MDR report key: 10857066 · Received November 17, 2020

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    Report

    Report Number
    2243072-2020-01849
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 21, 2020
    Report Date
    December 21, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 8324931 D.4. MEDICAL DEVICE EXPIRATION DATE: NA H.4. DEVICE MANUFACTURE DATE: 11/19/2018 H.6. INVESTIGATION: ACCORDING TO THE DHR REVIEW PROCESS; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE TROLLEY DAMAGED 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 TROLLEY DAMAGED FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. CCORDING WITH THIS INVESTIGATION AND THE INFORMATION PROVIDED FROM THE CUSTOMER (PHOTOS) IT COULD BE SEEN A NUT DAMAGED, A LOT NUMBER (8324931) MANUFACTURED IN 2018 AND A BOX FROM FLEX (RELABELED). FOR THIS REASON, IT CAN BE CONCLUDED THAT THERE ARE MANY VARIABLES THAT COULD GENERATE THIS FAILURE MODE AS INCORRECT HANDLING, NOT CONTROLLED REPACKAGING PROCESS, NOT SUITABLE PACKING, TRANSPORTATION DAMAGES, ETC. THEREFORE, ADDITIONAL INFORMATION (HANDLING METHOD USED BY THE DISTRIBUTOR, PHOTOS OF TRANSPORTATION) IS NEEDED TO DETERMINE THE POSSIBLE ROOT CAUSE THAT LEADS TO THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL SLIDE CLOSE 9 GAL RED KIT WAS DAMAGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT THE CART WAS DAMAGED ON ARRIVAL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HDQ (B)(4). THIS SITE IS AN (B)(4)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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHARPS COLL SLIDE CLOSE 9 GAL RED KIT WAS DAMAGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT THE CART WAS DAMAGED ON ARRIVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322708 SHARPS COLL SLIDE CLOSE 9 GAL RED KIT SHARPS CONTAINER MMK BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1