BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7242670 · Received February 5, 2018

    Report

    Report Number
    9610048-2018-00002
    Event Type
    Malfunction
    Date Received
    February 5, 2018
    Date of Event
    January 11, 2018
    Report Date
    February 20, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    K950301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN OPEN AND UNUSED SAMPLE OF THE ANGIOCATH PRODUCT WAS RECEIVED, ACCORDING TO VISUAL ANALYSIS IT CAN BE VERIFIED THAT THE CANNULA HAD GONE THROUGH THE CATHETER, A DEFECT KNOWN AS A "TRANSFIXED NEEDLE". THAT PORTION OF THE REPORTED DEFECT CAN BE CONFIRMED. OUR QUALITY ENGINEER WAS ABLE TO VERIFY THE CATHETER TIP INTEGRITY ISSUE BUT NOT THE FAILURE OF THE SAFETY DEVICE CLAIM. THE SAMPLE WAS RETURNED AND THE CATHETER WAS VERIFIED TO HAVE A TRANSFIXED NEEDLE. NO OBJECTIVE EVIDENCE OF THIS INCIDENT WAS FOUND DURING THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS ANALYSIS FOR THE CLAIMED LOT, THEREFORE, WE WERE UNABLE TO DETERMINE AN EXACT ROOT CAUSE. NOT CONFIRMED: FOR THE DEFECT "FAILURE OF THE SAFETY DEVICE", BD CANNOT CONFIRM THE CUSTOMER'S CLAIM FOR THE DEFECT CLAIMED, SINCE FOR THIS PRODUCT CATALOG "ANGIOCATH", DOES NOT HAVE SECURITY DEVICE. DHR REVIEW: THE INSYTE ASSEMBLED LOTS: 3024232, USED IN THE FINAL PRODUCT LOT: 3028439 OF ANGIOCATH 24GX0.75IN WERE ANALYZED REGARDING ¿DAMAGED COMPONENT¿ AND ¿NEEDLE THROUGH CATHETER¿ AND NO RECORDS THAT COULD LEAD TO CLAIMED DEFECT WERE FOUND. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NONCONFORMITY REPORT OF "DAMAGED COMPONENT" AND ¿NEEDLE THROUGH CATHETER¿ OR ANYTHING THAT COULD LEAD TO THIS COMPLAINT. UNPLANNED MAINTENANCE: DURING THE INVESTIGATIONS, THE HISTORY OF CORRECTIVE MAINTENANCE WAS EVALUATED DURING THE ASSEMBLY PERIOD OF THE LOT INVOLVED IN THIS COMPLAINT. AS A RESULT OF THIS ANALYSIS, NO RECORDS OF CORRECTIVE MAINTENANCE WERE EVIDENCED FOR REASON "CATHETER TEARING AT STATION # 04" THAT COULD LEAD TO THE INCIDENT IN QUESTION. BASED ON A SEVERITY ASSESSMENT AND OCCURRENCE IT WAS DETERMINED THAT NO CAPA IS REQUIRED AT THIS TIME. THE COMPLAINT WAS ADDED TO THE COMPLAINT DATABASE FOR TREND ANALYSIS, WHICH IS REGULARLY MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION, HOWEVER A NO SAMPLE INVESTIGATION HAS BEEN COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 3028439. UPON RECEIPT OF SAMPLES, A SECONDARY INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROFESSIONAL FOUND THE SAFETY MECHANISM MISSING ON A BD ANGIOCATH¿ IV CATHETER AFTER THE PUNCTURING PROCEDURE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83892 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3028439

    Patients

    Seq Age Sex Outcome Treatment
    1 Other