BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7143990 · Received December 22, 2017

    Report

    Report Number
    9610048-2017-00096
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 6, 2017
    Report Date
    January 23, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811121
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES/PHOTOS WERE RECEIVED TWO OPENED AND UNUSED SAMPLES OF ANGIOCATH 24GX0.75; CATALOG: 381112; BATCH: 6180339. A VISUAL ANALYSIS WAS PERFORMED ON THE SAMPLES, BUT DID NOT CONFIRM THE PRESENCE OF SILICONE DROPLETS ON THE CATHETER. DHR REVIEW: FINAL ASSEMBLY LOTS: 6152234SH AND 6179393 RESPECTIVELY USED IN THE CLAIMED FINAL PRODUCT BATCH: 6180339 OF ANGIOCATH YEL 24GA X 0.75IN WAS TESTED FOR PRESENCE OF "FOREIGN/NO FOREIGN MATTER" AND NO RECORDS OF THIS DEFECT WERE FOUND. QN/NCMR REVIEW: THERE ARE NO RECORDS OF QUALITY NOTIFICATION (QN) OR NON-CONFORMANCE REPORT (RNC) OF FOREIGN MATTER, FOR THE LOT INVOLVED IN THIS CLAIM, ACCORDING TO THE HISTORY OF THE LOT ABOVE. THE ROOT CAUSE FOR THIS CLAIM HAS NOT BEEN DETERMINED, SINCE THIS COMPLAINT WAS NOT BE CONFIRMED.

    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 BEFORE USE OF THE BD ANGIOCATH¿ IV CATHETER, A NURSE FOUND FOREIGN MATTER PARTICLES ON THE SURFACE OF CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923697 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6180339 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other