BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL NEXT GEN 5.4QT RED 20/PACK

    MDR report key: 12619561 · Received October 12, 2021

    Report

    Report Number
    2243072-2021-02493
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 13, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903055173
    PMA / PMN Number
    K943141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ACCORDING TO THE DHR REVIEW PROCESS; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE SHORT SHOT DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER REPORTED UNDER THIS CUSTOMER COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THAT ON LAST 12 MONTHS NO NCMRS HAS BEEN OPENED FOR SHORT SHOT FOR THE SAME PART NUMBER. AS PART OF THIS INVESTIGATION WITH THE PICTURE PROVIDE FROM CUSTOMER IT CAN CONFIRM THE FAILURE MODE REPORTED (SHORT SHOT) IS RELATED TO THE MANUFACTURING PROCESS, ALSO THE FOLLOWING EVIDENCE WAS NOTICED: 1. THE LOT NUMBER 1052914 WAS CONFIRMED TO BE MANUFACTURED BY FLEX. 2. THE SHORT SHOT CAN BE SEEN IN THE BASE. IN ACCORDANCE WITH THE COMPLAINT REPORTED A REVIEW TO THE CURRENT PROCESS WAS PERFORMED, AND IT WAS FOUND THAT EVERY TIME THAT MACHINE STARTS OPERATION, A MOLD CHANGE OR EVERY TIME THAT AN ADJUSTMENT IS REQUIRED, A SEGREGATION OF THE UNITS MOLDED MUST BE PERFORMED AND SCRAPPED. BASED ON MACHINE TECHNICAL EXPERTISE, THE FAILURE MODE PRESENTED ON PHOTOS SHOWS A UNIT THAT BELONG TO THESE KIND OF STOPPAGES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHARPS COLL NEXT GEN 5.4QT RED 20/PACK 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, THE RED BASE WAS FOUND TO BE PARTIALLY DAMAGED BEFORE USE.

    Additional Manufacturer Narrative · 1

    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. 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 SHARPS COLL NEXT GEN 5.4QT RED 20/PACK 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, THE RED BASE WAS FOUND TO BE PARTIALLY DAMAGED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514436 SHARPS COLL NEXT GEN 5.4QT RED 20/PACK HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305517 1052914 00382903055173

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown