BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 18253501 · Received December 3, 2023

    Report

    Report Number
    1710034-2023-01375
    Event Type
    Malfunction
    Date Received
    December 3, 2023
    Date of Event
    November 7, 2023
    Report Date
    January 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835127
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION (EVENT 1OF 2): NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383512 AND LOT NUMBER 3032872. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA HAD A HOLE IN THE CATHETER AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT TWO BD NEXIVA CLOSED IV CATHETERS HAD A HOLE IN THE PLASTIC AT THE END OF THE CATHETER TUBING. SALINE LEAKED OUT FROM THE HOLE IN THE PLASTIC. THEY WERE BOTH FROM THE SAME LOT NUMBER AND HAPPENED 2 DAYS IN A ROW. NEEDED TO START NEW IV'S, SO PATIENTS WERE STUCK MORE THAN NECESSARY. THE PATIENT IMPACT WAS THAT WE NEEDED TO STICK THEM AGAIN TO START A NEW IV SINCE THE REPORTED ONES WERE DEFECTIVE. I DO NOT HAVE ANY PHOTOS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA HAD A HOLE IN THE CATHETER AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT TWO BD NEXIVA CLOSED IV CATHETERS HAD A HOLE IN THE PLASTIC AT THE END OF THE CATHETER TUBING. SALINE LEAKED OUT FROM THE HOLE IN THE PLASTIC. THEY WERE BOTH FROM THE SAME LOT NUMBER AND HAPPENED 2 DAYS IN A ROW. NEEDED TO START NEW IV'S, SO PATIENTS WERE STUCK MORE THAN NECESSARY. THE PATIENT IMPACT WAS THAT WE NEEDED TO STICK THEM AGAIN TO START A NEW IV SINCE THE REPORTED ONES WERE DEFECTIVE. I DO NOT HAVE ANY PHOTOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430195 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3032872 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown