BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SHARPS COLLECTOR

    MDR report key: 13233217 · Received January 11, 2022

    Report

    Report Number
    2243072-2021-03107
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 17, 2021
    Report Date
    April 21, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903056354
    PMA / PMN Number
    K943139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: 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. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED. THE ADDITIONAL ATTEMPTS TO GET MORE INFORMATION WERE MADE HOWEVER IN NONE OF THE CASES ADDITIONAL INFORMATION WAS RETRIEVED. ACCORDING TO THE DHR REVIEW PROCESS, THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER (1082902) REPORTED UNDER THIS CUSTOMER COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR WAS MISSING A LID. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "ONE LID IS MISSING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR WAS MISSING A LID. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "ONE LID IS MISSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100844 BD¿ SHARPS COLLECTOR SHARPS COLLECTOR FMI BECTON DICKINSON 305635 1082902 00382903056354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown