BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH

    MDR report key: 21184028 · Received January 17, 2025

    Report

    Report Number
    9610048-2025-00003
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    January 2, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E. STREET ADDRESS EXCEEDS CHARACTER LIMIT: (B)(6). H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION- BATCH # PROVIDED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38833514 AND LOT NUMBER 4242786. ALTHOUGH NO QUALITY NOTIFICATIONS OR NON-CONFORMITY REPORTS WERE DOCUMENTED DURING THE PRODUCTION PROCESS, A CORRECTIVE MAINTENANCE ACTION WAS PERFORMED DURING THE MANUFACTURING PERIOD. THE MAINTENANCE ACTION PERFORMED VARIOUS ADJUSTMENTS AND ALIGNMENTS THAT MAY HAVE BEEN RELATED TO THIS DEFECT. AS SAMPLES WERE UNAVAILABLE FOR THIS EVENT, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. IT WAS DETERMINED THAT THE PROBABLE ROOT CAUSE IS RELATED TO THE FORMATION OF THE CATHETER TIP IN THE MANUFACTURING PROCESS. A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE AND PREVENT ANY REOCCURRENCE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ANGIOCATH CATHETER IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WE ARE EXPERIENCING RECURRING PROBLEMS WITH THE AFOREMENTIONED MATERIAL, WITH SOME UNITS NOT HAVING THE THREAD, WHILE OTHERS HAVE DEFORMITIES THAT MAKE IT DIFFICULT TO PUNCTURE PATIENTS. THESE FAILURES ARE GENERATING, IN ADDITION TO INCREASED COSTS DUE TO WASTED MATERIALS, A NEGATIVE IMPACT ON PATIENTS' COMFORT AND WELL-BEING, LOSING THE VEIN AND CONSEQUENTLY HURTING THE PATIENT. EVEN AFTER TRAINING WITH THE NURSE, THE PROBLEM REMAINS, AS SHE WAS ABLE TO SEE FOR HERSELF.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION UNRELATED TO EVENT DESCRIPTION OR PROBLEM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140665 BD ANGIOCATH PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4242786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown