BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD DURASAFE¿ COMBINED ANESTHESIA KIT

    MDR report key: 6805729 · Received August 18, 2017

    Report

    Report Number
    9610048-2017-00015
    Event Type
    Injury
    Date Received
    August 18, 2017
    Date of Event
    July 25, 2017
    Report Date
    September 11, 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

    INVESTIGATION SUMMARY: SAMPLES/ PHOTOS: SAMPLES OR PHOTOS HAVE NOT RECEIVED FOR ANALYSIS OF THE INCIDENT IN QUESTION. RETAIN SAMPLE EVALUATION: NOT APPLY. 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. INVESTIGATION CONCLUSION: NOT CONFIRMED: BD WAS UNABLE TO CONFIRM OR REPRODUCE THE COMPLAINT. ALTHOUGH THE COMPLAINT REPORT DESCRIBED A RUPTURE OF THE EPIDURAL CATHETER USED IN THE ANESTHESIA TRAY, THE INCIDENT WAS NOT CONFIRMED AS BEING CAUSED BY THE TRAY ASSEMBLY PROCESS. THE EPIDURAL CATHETER IS A COMPONENT USED TO MOUNT THE ANESTHESIA TRAY AND IS PURCHASED FROM AN EXTERNAL SUPPLIER (TELEFLEX). IN THIS WAY, THE RUPTURE OF THE CATHETER DOES NOT ORIGINATE FROM THE ASSEMBLY OF THE TRAY. IN ADDITION, IT WAS FOUND THAT IF THE CATHETER HAD ALREADY RUPTURED PRIOR TO ITS USE, IT COULD NOT BE USED DURING THE PROCEDURE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, IT WAS NOT POSSIBLE TO ATTRIBUTE A ROOT CAUSE TO THE INCIDENT IN QUESTION UP TO DATE. RATIONALE: 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. OTHER TAKEN ACTION: EVEN IF THE INCIDENT HAS NOT BEEN CONFIRMED, THE TELEFLEX PROVIDER WAS INFORMED OF THE INCIDENT IN QUESTION.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CONSUMER THAT WHEN INSERTING A CATHETER USING A BD DURASAFE¿ COMBINED ANESTHESIA KIT, A PIECE OF THE GUIDEWIRE REMAINED IN THE PATIENT. A SCOPE, RESONANCE, AND TOMOGRAPHY AND NEURO SURGERY WERE PERFORMED. APPROXIMATELY 6CM OF THE CATHETER WAS REMOVED. THE PATIENT WAS OBSERVED AND DID NOT PRESENT LESIONS OR NEURAL ALTERATIONS AND WAS DISCHARGED FROM HOSPITAL AFTER HER/HIS SURGICAL TREATMENT. THE PATIENT WAS CONSTANTLY MONITORED AND HAD NO ALTERATIONS. PATIENT DISCHARGED FROM HOSPITAL AND WILL BE MONITORED BY THE INSTITUTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585839 BD DURASAFE¿ COMBINED ANESTHESIA KIT ANESTHESIA COMBINED SPINAL & EPIDURAL KIT CAZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6362812

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention