BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCALP BD¿ ASEPTO 21G CATHETER

    MDR report key: 7196728 · Received January 16, 2018

    Report

    Report Number
    9610048-2017-00108
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 22, 2017
    Report Date
    January 23, 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 · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: OUR QUALITY ENGINEER WAS ABLE TO VERIFY THE REPORTED COMPLAINT. ACCORDING TO VISUAL ANALYSIS OF THE SAMPLE IT CAN BE VERIFIED THAT THERE WAS A HOLE IN THE PRODUCT TUBE, WHICH CAN CAUSE LEAKAGE IN ITS USE. THE ROOT CAUSE FOR THIS INCIDENT WAS A MISALIGNMENT OF THE CLAWS THAT TAKE THE TUBE TO ASSEMBLY THE WING INSIDE IT, WHICH CAUSED A HOLE IN THE TUBE. MAINTENANCE WAS PERFORMED TO ADJUST THE CLAW AND THE POSITION OF THE EXCHANGE. ALSO THE OPERATORS WILL BE NOTIFIED OF THE EVENT. CONFIRMED: BD WAS ABLE TO CONFIRM THE INCIDENT IN QUESTION. INVESTIGATION COMMENTS: BESIDES THE ANALYSIS OF THE SAMPLE RETURNED FROM THE CUSTOMER, IT HAS BEEN EVIDENCED A HOLE ON THE TUBE THE ANALYSIS OF THE CORRECTIVE MAINTENANCE HISTORY SHOWED "TUBE NIPPED" DURING THE MANUFACTURE OF LOT 7116548, WHICH WAS ENOUGH TO CONFIRM THIS COMPLAINT. SAMPLES/ PHOTOS: IT WAS RECEIVED ONE OPEN AND UNUSED SAMPLE OF SCALP 21G PRODUCT, CATALOG: 388337, LOT: 7173756 FOR ANALYSIS. ACCORDING TO VISUAL ANALYSIS OF THE SAMPLE IT CAN BE VERIFIED THAT THERE WAS A HOLE IN THE PRODUCT TUBE, WHICH CAN CAUSE LEAKAGE IN ITS USE. DHR REVIEW: THE FOLLOWING ASSEMBLED WING (CODE: 004650BJF) LOT USED IN THE CLAIMED FINAL PRODUCT LOT 7173756 WAS ANALYZED: 7116548 ASSEMBLED ON MACHINES 5006-1, 2 AND 3 IN THE PERIOD FROM 05/16 TO 05/31/2017; THE BATCH IN QUESTION WAS ANALYZED AS TESTS OF "DAMAGED COMPONENT" AND NO RECORDS OF THIS DEFECT WERE DETECTED FOR THE BATCH 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. UNPLANNED MAINTENANCE: CORRECTIVE MAINTENANCE HISTORY WAS EVALUATED IN THE PERIOD OF FINAL ASSEMBLY OF PRODUCT AND THE CORRECTIVE MAINTENANCE # (B)(4) IN THE SORTIMAT # 5006-1 MACHINE WAS EVIDENCED. REASON: "TUBE NIPPED". ACCORDING TO INVESTIGATIONS PERFORMED THESE MAINTENANCES MAY LEAD TO REPORTED OCCURRENCE IN THIS COMPLAINT. CONCLUSION: BASED ON THE INVESTIGATIONS, IT WAS VERIFIED THAT THE ROOT CAUSE FOR THIS INCIDENT WAS CAUSED BY A MISALIGNMENT OF THE CLAWS THAT TAKE THE TUBE TO ASSEMBLY THE WING INSIDE IT, WHICH CAUSED A HOLE IN THE TUBE LEADING TO THE INCIDENT IN QUESTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS LEAKAGE FOUND ON A SCALP BD¿ ASEPTO 21G CATHETER DURING USE. THE MATERIAL WAS REPORTED TO HAVE A CRACK, MAKING IT IMPOSSIBLE TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41905 SCALP BD¿ ASEPTO 21G CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7173756

    Patients

    Seq Age Sex Outcome Treatment
    1 Other