BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCALP BD¿ ASEPTO CATHETER

    MDR report key: 7101244 · Received December 8, 2017

    Report

    Report Number
    9610048-2017-00092
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 7, 2017
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE CUSTOMER, IT WAS EVIDENCED THAT THE NEEDLE HAS GLUES ON THE CANNULA, THE ANALYSIS OF THE CORRECTIVE MAINTENANCE HISTORY SHOWED "BAD APPLICATION OF GLUE" DURING THE MANUFACTURE OF LOT 7149712, WHICH IS ENOUGH TO CONFIRM THIS COMPLAINT. SAMPLES/ PHOTOS: IT WAS RECEIVED ONE OPEN AND UNUSED SAMPLE OF ASEPTO 25G PRODUCT, CATALOG: 388339, LOT: 7173777 FOR ANALYSIS. ACCORDING TO VISUAL ANALYSIS OF THE SAMPLE IT CAN BE VERIFIED THAT THE SAMPLE HAS DROPS OF GLUE ON THE NEEDLE BODY. DHR REVIEW: THE FOLLOWING ASSEMBLED WING (CODE: 004642BJF) LOTS USED IN THE CLAIMED FINAL PRODUCT LOT 7173777 WERE ANALYZED: 7087505 ASSEMBLED ON MACHINES 5004 AND 5005 IN THE PERIOD FROM 06 TO 17 APRIL, 2017; 7149712 ASSEMBLED ON MACHINES 5004 AND 5005 IN THE PERIOD FROM 02 TO 06 JUNE, 2017; THE BATCHES IN QUESTION WERE ANALYZED AS TEST OF "CANNULA DIRTY OF GLUE" AND NO RECORDS OF THIS DEFECT WERE DETECTED FOR THE BATCHES ANALYZED. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NON-CONFORMITY REPORT RECORDS THAT COULD LEAD TO THIS ISSUE FOR THE LOTS INVOLVED IN THIS COMPLAINT. BASED ON THE INVESTIGATIONS, IT WAS VERIFIED THAT THE ROOT CAUSE FOR THIS INCIDENT WAS CAUSED BY A FAILURE IN THE APPLICATION OF THE NEEDLE GLUE IN THE WING, CAUSING DROPS OF THIS GLUE TO REACH THE NEEDLE BODY GENERATING THE INCIDENT DESCRIBED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE SCALP BD¿ ASEPTO CATHETER THE MATERIAL CONTAINS SLOTS, ROUGHNESS, CURLING. THE NEEDLE COLOR IS DIFFERENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881467 SCALP BD¿ ASEPTO CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7173777

    Patients

    Seq Age Sex Outcome Treatment
    1 Other