BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿

    MDR report key: 7516239 · Received May 15, 2018

    Report

    Report Number
    9610048-2018-00057
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    April 2, 2018
    Report Date
    May 17, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLES/ PHOTOS: SAMPLES HAVE NOT RECEIVED FOR ANALYSIS OF THE INCIDENT IN QUESTION. OUR QUALITY ENGINEER WAS UNABLE TO VERIFY THE REPORTED COMPLAINT. DHR REVIEW: THE INSYTE LOT: 7207751 WAS ASSEMBLED IN ICAM #02 IN THE PERIOD BETWEEN 21 AND 31 AUGUST, 2017, USED IN THE FINAL PRODUCT LOT: 7241931 OF INSYTE 22G 1,00 WAS ANALYZED REGARDING THE TEST OF "LOOSE FILTER PLUG" AND WERE NOT EVIDENCED RECORDS THAT COULD LEAD TO THE CLAIMED DEFECT. THE PACKAGED LOT: 7241931 WAS MANUFACTURED IN R530-2 MACHINE ON 09/07/2017 AND NO RECORDS OF "MISSING COMPONENT" WERE EVIDENCED. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NONCONFORMITY REPORT OF "LOOSEN FILTER PLUG¿ OR SOMETHING THAT COULD LEAD TO THIS COMPLAINT. BASED ON THE INVESTIGATION RESULTS TO DATE THE ROOT CAUSE WAS NOT DETERMINED FOR THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED DEFECT WILL CONTINUE TO BE TRACKED AND TRENDED. THE INFORMATION WILL BE CAPTURED IN THE TREND REPORTS AND MONITORED MONTHLY. COLLECTED DATA ARE REGULARLY REVIEWED TO IDENTIFY EMERGING TRENDS. BASED ON THIS, A CAPA IS NOT NEEDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENT PLUG ON A BD INSYTE¿ WAS MISSING BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358448 BD INSYTE¿ INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7241931

    Patients

    Seq Age Sex Outcome Treatment
    1 Other