BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ PLUS

    MDR report key: 7927303 · Received October 2, 2018

    Report

    Report Number
    8041187-2018-00354
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    May 30, 2018
    Report Date
    October 10, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE RETURNED FOR INVESTIGATION. NO ACTUAL SAMPLE WAS RETURNED. DRH REVIEW OF PACKAGED NEEDLE BATCH 7236361 CATALOGUE NUMBER 382423 AND ITS ASSEMBLED NEEDLE BATCH 7236402, 7201166 PART NUMBER 8365077 SHOWED NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. THE NONCONFORMANCE CANNOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR INVESTIGATION. THE COMPLAINT WILL BE REOPENED IF THE SAMPLE IS RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICATION LEAKED FROM THE BD ANGIOCATH PLUS CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICATION LEAKED FROM THE BD ANGIOCATH¿ PLUS CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767470 BD ANGIOCATH¿ PLUS INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7236361

    Patients

    Seq Age Sex Outcome Treatment
    1 Other