BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NESTABLE SHARPS COLLECTOR

    MDR report key: 15491159 · Received September 27, 2022

    Report

    Report Number
    2243072-2022-01630
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 12, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. 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. INITIAL REPORTER PHONE#: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. 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

    H6: INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED. A DHR REVIEW PROCESS WAS MADE AND THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER REPORTED (2041939) UNDER THIS COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THAT NO MISSING LIDS ISSUES WERE REPORTED FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. BASED ON INFORMATION PROVIDED IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE LIKE A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS SINCE INFORMATION SUCH AS METHOD USED TO HANDLE, SHIPPED PARTIAL SELLS AND CONTROLS TO STORAGE THE REMAINING PRODUCT WITHIN DISTRIBUTOR FACILITY IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ NESTABLE SHARPS COLLECTOR WAS MISSING ITS LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): THIS IS A REPORT ABOUT A MISSING LID OF SHARPS COLLECTOR. ACCORDING TO THE DISTRIBUTOR'S REPORT, ONE LID WAS MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ NESTABLE SHARPS COLLECTOR WAS MISSING ITS LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT A MISSING LID OF SHARPS COLLECTOR. ACCORDING TO THE DISTRIBUTOR'S REPORT, ONE LID WAS MISSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078379 BD¿ NESTABLE SHARPS COLLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305487 2041939 00382903054879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown