BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 18461383 · Received January 7, 2024

    Report

    Report Number
    9610048-2023-00118
    Event Type
    Malfunction
    Date Received
    January 7, 2024
    Date of Event
    November 28, 2023
    Report Date
    August 8, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 3818214 AND LOT NUMBER 3132130. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. ONE (1) PICTURE SAMPLE WAS RECEIVED; HOWEVER, THE PICTURE DID NOT SHOW THE SILICONE CATHETER COMPONENT. THROUGH EVALUATION OF THE PICTURE, IT COULD ONLY BE OBSERVED THAT THE PRODUCT¿S SAFETY DEVICE WAS ACTIVATED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT OF CATHETER RUPTURE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    EVENT DATE RECEIVED AND ADDITIONAL INFORMATION RELATED TO PATIENT OUTCOME SUPPORTING NO SI ALSO ADDED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    RESPONSE RECEIVED ON 26DEC2023: WAS THERE ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? NO. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENT (IMAGING TESTS, SURGERY, DRUG ADMINISTRATION, ETC.)? NO. WAS THERE ANY EXPOSURE OF BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF SO, PLEASE STATE WHETHER THE EXPOSURE WAS THE PATIENT'S OR THE PROFESSIONAL'S AND WHAT MEASURES WERE TAKEN. NO. RESPONSE RECEIVED ON 04JAN2024. WHAT MEDICATION WAS BEING ADMINISTERED? - NO REPORTS. INFO RECEIVED ON 09JAN2024. DATE OF EVENT : 28/11/2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETER 'RUPTURE' DURING INSERTION PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: I HEREBY INFORM YOU THAT A NOTIFICATION HAS BEEN OPENED WITH NOTIVISA DUE TO A POSSIBLE QUALITY DEVIATION, ABOCATH SHOWING A RUPTURE IN THE SILICONE AT THE TIME OF PHLEBOTOMY. IN ACCORDANCE WITH OUR INTERNAL TECHNOVIGILANCE PROCEDURE, WE ARE NOTIFYING YOU SO THAT WE CAN ASSESS AND ADAPT THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601599 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3132130 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown