BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS COLL 1.5QT RED

    MDR report key: 13869184 · Received March 23, 2022

    Report

    Report Number
    2243072-2022-00380
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 7, 2022
    Report Date
    May 16, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903054879
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: UNKNOWN. DEVICE MANUFACTURE DATE: 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

    INVESTIGATION SUMMARY: ACCORDING TO THE DHR REVIEW PROCESS, THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE LID WILL NOT SHUT ISSUE DURING THE MANUFACTURING PROCESS OF THE LOT NUMBERS REPORTED (1105905, 1152926, 1106904) UNDER THIS CUSTOMER COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE LID WILL NOT SHUT ISSUE FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. BASED ON THIS INVESTIGATION, PICTURES AND A VIDEO WERE PROVIDED, AS WELL AS THE DESCRIPTION OF THE CUSTOMER REPORT WHERE IT IS MENTIONED THAT THE LID OPENS SPONTANEOUSLY AFTER IT IS SHUT, IN ORDER TO DETERMINE THE ROOT CAUSE OF THIS PROBLEM. AN ENGINEERING STUDY WAS PERFORMED DUE TO THE NEGATIVE TRENDING REPORTED FROM JAPAN TO EVALUATE FUNCTIONALITY ON TEMPORARY CLOSURE, OBTAINING THE FOLLOWING ¿ AFTER 24 HOURS, NONE OF THE TESTED LIDS WENT OPEN BY THEMSELVES. ¿ ALL THE TESTED PARTS REQUIRE A MINIMUM FORCE GREATER THAN 1.5LBF TO DISENGAGE THE TEMPORARY CLOSURE. ¿ ALL THE MATERIAL MET THE EXPECTED RESULTS. BASED ON THE RESULT OF THIS INVESTIGATION, THIS IS NOT FAILURE MODE RELATED TO THE MANUFACTURING PROCESS BECAUSE THE ISSUE REPORTED IS A FUNCTIONAL TEST NOT REQUIRED BY CUSTOMER SPECIFICATION, THEREFORE NEITHER IS EVALUATED WITHIN THE PROCESS INSPECTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SHARPS COLL 1.5QT RED WOULD NOT STAY SHUT. THE EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "THE CUSTOMER'S REPORT IS THAT THE HCP SHUTS THE LID BUT THE LID DOES NOT REMAIN SHUT AND SOON BECOMES OPEN."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SHARPS COLL 1.5QT RED WOULD NOT STAY SHUT. THE EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "THE CUSTOMER'S REPORT IS THAT THE HCP SHUTS THE LID BUT THE LID DOES NOT REMAIN SHUT AND SOON BECOMES OPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714624 BD SHARPS COLL 1.5QT RED HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN 00382903054879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown