BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NESTABLE SHARPS COLECTOR

    MDR report key: 12305032 · Received August 10, 2021

    Report

    Report Number
    2243072-2021-02045
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 5, 2021
    Report Date
    September 23, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903054879
    PMA / PMN Number
    K943139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: AN UNUSED SAMPLE WAS RETURNED AND PHOTOS WERE FORWARDED FOR INVESTIGATION. ACCORDING TO THE DHR REVIEW PROCESS, THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE LIDS BROKEN OR CRACKED DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER (1003902) REPORTED UNDER THIS CUSTOMER COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE BROKEN OR DAMAGE ISSUE FOR THE SAME PART NUMBER (305487) THROUGHOUT THE LAST TWELVE MONTHS (SEP-2020 THRU SEP-2021). FLEX PACKAGE FOR THIS PRODUCT HAS 36 PCS ACCORDING WITH THE STANDARD PACK, ADDITIONALLY THE PART BROKEN WAS ARRIVED AS A PART OF THE SHIPMENT AT THE USER ON JAPAN. THERE ARE PROBABILITIES OF THIS PRODUCT WAS MANIPULATED AND CHANGED FROM THE ORIGINAL PACKAGING TO A NON-SUITABLE PACKAGING. OR THE PRODUCT CAN BE DAMAGE DURING THE TRANSPORTATION FROM THE DISTRIBUTOR AT THE FINAL USER. WITH ALL THIS INFORMATION IT WAS CONCLUDED THAT THIS PRODUCT HAD ADDITIONAL HANDLING BY A DISTRIBUTOR. FOR THIS REASON, IT CAN BE CONCLUDED THAT THERE ARE MANY VARIABLES THAT COULD GENERATE THIS FAILURE MODE BECAUSE THE DISTRIBUTORS CAN DO PARTIAL SELLS AND THE CONTROLS TO HANDLE REMAINING MATERIAL IS UNKNOWN, THEREFORE, THE LIKELIHOOD OF NON-CONTROLLED HANDLING WITHIN DISTRIBUTOR FACILITIES COULD HAPPEN AND LEADS TO PRODUCT DAMAGES. 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 THE BD¿ NESTABLE SHARPS COLECTOR EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DAMAGED BASE OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, WHEN OPENING THE CARTON, THE BASE (RED) WAS FOUND TO BE DAMAGED AT ITS CORNER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ NESTABLE SHARPS COLLECTOR EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DAMAGED BASE OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, WHEN OPENING THE CARTON, THE BASE (RED) WAS FOUND TO BE DAMAGED AT ITS CORNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196660 BD NESTABLE SHARPS COLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305487 1003902 00382903054879

    Patients

    Seq Age Sex Outcome Treatment
    1