BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ PLUS IV CATHETER

    MDR report key: 17507459 · Received August 11, 2023

    Report

    Report Number
    9610048-2023-00083
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 24, 2023
    Report Date
    November 8, 2023
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811237
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 381123 AND LOT NUMBER 2070008. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, NO DEFECTS WERE IDENTIFIED WITH THE CATHETER TIP. BASED ON THE INVESTIGATION RESULTS, A CAUSE COULD NOT BE DETERMINED FOR THE REPORTED 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

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED THIS IS A REPORT ABOUT A DAMAGED CATHETER TIP. THE CATHETER TIP WAS JAGGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ANGIOCATH¿ PLUS IV CATHETER TIP WAS JAGGED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DAMAGED CATHETER TIP. THE CATHETER TIP WAS JAGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783454 BD ANGIOCATH¿ PLUS IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 2070008 30382903811237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown