BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CATHETER

    MDR report key: 7866263 · Received September 11, 2018

    Report

    Report Number
    3006948883-2018-00174
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    August 21, 2018
    Report Date
    September 19, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD FOR LOT# 8043044 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND DURING THE MANUFACTURING PROCESS. THE ACTUAL SAMPLE WAS PROVIDED FOR THIS COMPLAINT, THE ACTUAL SAMPLE WAS EVALUATED AND DID SHOW THE REPORTED FAILURE MODE IN WHICH CONFIRMED THIS COMPLAINT. BD INVESTIGATORS SUBJECTED THE RETURNED SAMPLE TO LEAKAGE TESTING AND IDENTIFIED A SMALL BREACH IN THE EXTENSION TUBING THAT HAD CHARACTERISTICS CONSISTENT WITH A PUNCTURE ORIGINATING FROM THE INTERIOR OF THE TUBING. EVALUATION OF THE MANUFACTURING LINE DETERMINED THAT THE ROOT CAUSE FOR THIS COMPLAINT IS WORN OR DAMAGED MACHINERY. THE APPROPRIATE COMPONENTS HAVE BEEN REPLACED AND BD IS CURRENTLY SEEKING WAYS TO OPTIMIZE THIS ZONE OF PRODUCTION TO ELIMINATE THE REOCCURRENCE OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INTIMA-II CATHETER THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF 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 WITH THE USE OF THE BD INTIMA-II¿ CATHETER THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706822 BD INTIMA-II¿ CATHETER INTERVASCULAR CATHETER FOZ BD (SUZHOU) 8043044

    Patients

    Seq Age Sex Outcome Treatment
    1 Other