BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH

    MDR report key: 19311330 · Received May 14, 2024

    Report

    Report Number
    9610048-2024-00053
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 11, 2024
    Report Date
    September 27, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903811236
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 381123 AND LOT NUMBER 1110980. 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. PER THE INFORMATION RECEIVED REGARDING THE SAMPLE RETURN, NO SAMPLES BELONGING TO ANGIOCATH MATERIAL 381123 WERE RETURNED (SAMPLES BELONGED TO RELATED (B)(4) ¿ INSYTE MATERIAL 381211). THEREFORE, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. 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

    (B)(6)2024: COULD YOU CONFIRM WHETHER THERE HAVE BEEN NEGATIVE CONSEQUENCES FOR THE PATIENT? (SERIOUS INJURIES, MEDICAL INTERVENTION, NEED TO CHANGE TREATMENT)? NO, NO CONSEQUENCES PLEASE PROVIDE AN EVENT DATE: (B)(6)2024. HAS THERE BEEN AN EXPOSURE OF HEALTH CARE PERSONNEL TO BLOOD OR BODY FLUIDS? NO. HAVE ANY OTHER ACTIONS BEEN TAKEN? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ANGIOCATH CANNULA BREAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: HE FOUND IT DIFFICULT TO USE AS THEY "SLIDE WITH DIFFICULTY AND THE CANNULA BREAKS". HE TESTED ON 5 PCS OF CODE 381123 (BLUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648330 BD ANGIOCATH PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 1110980 00382903811236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown