BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MAGIC 3 GO COUDE

    MDR report key: 17336844 · Received July 14, 2023

    Report

    Report Number
    MW5119510
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    August 10, 2021
    Report Date
    July 12, 2023
    Manufacturer
    BARD / C.R. BARD, INC.
    Product Code
    EZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I JUST LEARNED BARD(THE MANUFACTURER C.R. BARD INC., A WHOLLY OWNED SUBSIDIARY OF BD (BECTON, DICKINSON, & COMPANY), HAS A RECALL ON CERTAIN CATHETERS. BARD MAGIC 3 GO 50814G CATHETERS HAD A PROBLEM 2 1/2 YEARS AGO AND THEY DID NOT WISH TO ANNOUNCE A RECALL WAS NECESSARY. I RETURNED THE BAD CATHETERS TO BARD AND 6 MONTHS LATER ALL THEY REPORTED WAS "POSSIBLE INTERNAL OR EXTERNAL DAMAGE". THE CATHETERS ACTUALLY HAD A "BURR" ON THE TIP THAT CAUSED BLEEDING WHEN INSERTED. CASE NUMBERS FROM BARD WERE (B)(4). THEIR QUALITY CONTROL IS ACTUALLY LIBERATOR WHO SELLS PRODUCT, NOT MANUFACTURER. IN AUGUST/SEPTEMBER OF 2021, SEVERAL EMAILS WERE SENT TO (B)(4) (BARD MANAGER IN MARKETING) AND TO ONE OF THEIR EXECUTIVE VP'S ABOUT A MONTH AGO. NEVER RECEIVED A RESPONSE FROM EITHER. I EVEN REFERENCED THE "FILE OR CASE" NUMBERS RELATED TO MY FAULTY CATHETERS. I WOULD SAY THEY HAVE ABOUT 10 MANAGERS & VP'S FOR EVERY 10 WORKERS. REFERENCE REPORTS MW5119509, MW5119511, MW5119512.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101396 BARD MAGIC 3 GO COUDE CATHETER, STRAIGHT EZD BARD / C.R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other