BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21112588 · Received January 9, 2025

    Report

    Report Number
    9610048-2024-00215
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 13, 2024
    Report Date
    April 30, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER CONFIRMS THAT THE CATHETER BROKE. UPDATED IN B. NARRATIVE.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38182314 AND LOT NUMBER 4242799. 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. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. IF THE AFFECTED SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THEM. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 01/16/2025. IT IS STATED THAT IT IS FRAGILE AND BREAKS... PLEASE CONFIRM IF THE CATHETER SHEATH BREAKS OR IF THE METAL NEEDLE BREAKS. A: CATHETER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETER VS. NEEDLE BREAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: FRAGILE, IT BREAKS WHEN INSERTED, THE MANDREL HAS NO CUT, MAKING IT DIFFICULT TO PUNCTURE AND INJURING THE SKIN. ADDITIONAL INFORMATION RECEIVED ON 12/18/2024 IS THERE ANY PATIENT IMPACT, IF YES, PLEASE EXPLAIN IN DETAILS? A: IT HURTS PATIENTS' SKIN BECAUSE IT IS BLUNT, FRAGILE AND BREAKS. COULD YOU PLEASE SHARE THE PHOTO SAMPLES RELATED TO THIS EVENT? A: I DON'T HAVE ANY CAN YOU PLEASE CONFIRM THE DATE OF EVENT? A: 13/12. WAS ANVISA NOTIFIED? IF YES, WHAT WAS THE NOTIFICATION NUMBER? A: 2024.12.002397. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENCE (IMAGING TESTS, SURGERY, DRUG ADMINISTRATION, ETC.)? (DETAIL). A: NO. WAS THERE EXPOSURE OF BLOOD/CHEMOTHERAPY TO MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF YES, INDICATE WHETHER THE EXPOSURE WAS FROM THE PATIENT OR THE PRACTITIONER AND WHAT MEASURES WERE TAKEN. (DETAIL). A: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417777 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4242799 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown