BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40 IN EXT W/2 VLV PORTS

    MDR report key: 19198287 · Received April 26, 2024

    Report

    Report Number
    9616066-2024-00643
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 2, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    10885403235276
    PMA / PMN Number
    K022209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY CUSTOMER THAT THEY EXPERIENCE LEAKING. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF LEAKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 37262E LOT NUMBER 24029188 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 07FEB2024. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL #: UNKNOWN. BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY EXPERIENCE LEAKING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. IT HAS BEEN BROUGHT TO OUR ATTENTION THAT EITHER, LAWSON # 133750 IV EXT SET W/2 NEDL FREE SITES REF# 37262E OR LAWSON # 104516 NEEDLE IV AUTOGUARD 22G REF # 382532. IS LEAKING. THEY COULD NOT DUPLICATE THE ISSUE WITH DIFFERENT ITEMS BUT ARE CONCERNED. JUST WANTED YOU TO BE AWARE IN CASE ANY OTHER TEAM MEMBERS ARE REPORTING ISSUES WE ARE EXPERIENCE LEAKING WITH EITHER ITEM # 37262E OR 382532 IN THE ED. CAN YOU PLEASE HELP AT XXXX?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870860 40 IN EXT W/2 VLV PORTS SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON 24029188 10885403235276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown