BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY

    MDR report key: 16030206 · Received December 21, 2022

    Report

    Report Number
    8041187-2022-00761
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    December 3, 2022
    Report Date
    January 11, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868612
    PMA / PMN Number
    K220584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 OUR QUALITY ENGINEER INSPECTED THE 3 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF NEEDLE THROUGH CATHETER WAS CONFIRMED UPON INSPECTION OF THE PHOTOS. HOWEVER, BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. EVICE HISTORY RECORD OF PACKAGED NEEDLE (PN) BATCH 2141048 CATALOGUE NUMBER 386861 AND ITS ASSEMBLED NEEDLE (AN) BATCH 2146026 AND 2110615, PART NUMBER 8608861 WERE REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE FOR THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY WHILE INTRODUCING IT INTO THE VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WAS INSERTING AN IV INTO THE PATIENT AND WHEN I WENT TO THREAD THE CATHETER INTO THE VEIN, THE NEEDLE BUSTED THROUGH THE CATHETER LENGTH-WAYS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY WHILE INTRODUCING IT INTO THE VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WAS INSERTING AN IV INTO THE PATIENT AND WHEN I WENT TO THREAD THE CATHETER INTO THE VEIN, THE NEEDLE BUSTED THROUGH THE CATHETER LENGTH-WAYS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2839869 BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 386861 2141048 00382903868612

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown