BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DURASAFE¿ COMBINED ANESTHESIA KIT

    MDR report key: 6938740 · Received October 10, 2017

    Report

    Report Number
    3003916417-2017-00056
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 12, 2017
    Report Date
    November 3, 2017
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    CAZ
    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

    SAMPLES OR PHOTOS HAVE NOT RECEIVED FOR ANALYSIS OF THE INCIDENT IN QUESTION. DHR/ QN/ NCMR REVIEW: LOT 6362812 OF THE PRODUCT CONTINUOUS EPIDURAL ANESTHESIA TRAY, (B)(4) WAS ANALYZED FOR THE DAMAGED PRODUCT TESTS AND NO RECORDS OF NON-COMPLIANCE OR ANYTHING THAT COULD LEAD TO THE INCIDENT IN QUESTION WERE REPORTED FOR THE CLAIMED LOT. IN ADDITION, THERE ARE NO RECORDS OF NON-CONFORMANCE RELATED TO THIS INCIDENT FOR THE EPIDURAL CATHETER COMPONENT, (B)(4), LOT: 6081181 USED IN THE CLAIMED TRAY. EPIDURAL CATHETER IS A COMPONENT USED TO MOUNT THE ANESTHESIA TRAY AND IS PURCHASED FROM AN EXTERNAL SUPPLIER (TELEFLEX). THIS WAY, THE DIFFICULTY PRESENTED WITH THE CATHETER DOES NOT COME FROM THE TRAY ASSEMBLY. NOT CONFIRMED: BD WAS UNABLE TO CONFIRM OR REPRODUCE THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, THE GUIDE WIRE BD DURASAFE¿ COMBINED ANESTHESIA KIT WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716997 BD DURASAFE¿ COMBINED ANESTHESIA KIT ANETHESIA COMBINED SPINAL & EPIDURAL KIT CAZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6362812

    Patients

    Seq Age Sex Outcome Treatment
    1 Other