BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7130765 · Received December 19, 2017

    Report

    Report Number
    1710034-2017-00478
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 1, 2017
    Report Date
    January 30, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811374
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: MEDICAL DEVICE BRAND NAME HAS BEEN CORRECTED. THE MANUFACTURER ORIGINALLY REPORTED IS INCORRECT. THE CORRECT MANUFACTURER HAS BEEN UPDATED IN THESE SECTIONS. PMA / 510(K)#: K151698.

    Additional Manufacturer Narrative · 1

    AS PHOTOS OR SAMPLES ARE NOT AVAILABLE FOR ANALYSIS OF THIS COMPLAINT AND THE FACT THAT THE BATCH NUMBER WAS NOT INFORMED FOR ANALYSIS, IT WAS NOT POSSIBLE TO CONFIRM THIS COMPLAINT. IT WAS NOT POSSIBLE TO PERFORM A DEVICE HISTORY RECORD ANALYSIS, SINCE THE CLAIMED BATCH IS UNKNOWN. IT WAS NOT POSSIBLE TO PERFORM QUALITY NOTIFICATION (QN) OR NON-CONFORMITY REPORT RECORDS ANALYSIS SINCE THE CLAIMED BATCH IS UNKNOWN. BASED SOLELY ON THE INFORMATION CONTAINED IN THIS COMPLAINT, THE ROOT CAUSE FOR THIS CLAIM HAS NOT BEEN DETERMINED, SINCE THIS COMPLAINT WAS NOT BE CONFIRMED. 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

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER, DESCRIBED AS ¿LUBE¿, WAS ON THE CATHETER OF THE BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909700 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. UNKNOWN 30382903811374

    Patients

    Seq Age Sex Outcome Treatment
    1 Other