BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SP WITH MAXZERO¿

    MDR report key: 9539384 · Received January 2, 2020

    Report

    Report Number
    9610847-2019-00791
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 12, 2019
    Report Date
    February 6, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903835578
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9143739 AND THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. TO FURTHER INVESTIGATE THIS INCIDENT, ONE PHYSICAL SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PROVIDED SAMPLE, THE CLAMP WAS OBSERVED MISSING FROM THE PRODUCT. IT HAS BEEN DETERMINED THAT THIS INCIDENT WAS A RESULT OF OPERATOR ERROR WITHIN THE MANUFACTURING FACILITY. THE OPERATOR DID NOT IDENTIFY THE DEFECTIVE PRODUCT DURING VISUAL INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING CLAMP WAS MISSING WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SP WITH MAXZERO¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CLAMP WAS MISSING.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT THE TUBING CLAMP WAS MISSING WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SP WITH MAXZERO¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CLAMP WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4792 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SP WITH MAXZERO¿ INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383557 9143739 30382903835578

    Patients

    Seq Age Sex Outcome Treatment
    1 Other