BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 24 GA 0.75 IN

    MDR report key: 9869492 · Received March 23, 2020

    Report

    Report Number
    9610847-2020-00107
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 25, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903835904
    PMA / PMN Number
    K173354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 9232125. 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 24 GA 0.75 IN HAD AIR BUBBLES IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ONLY A SMALL AMOUNT OF BLOOD FILLED THE TUBING AND DID NOT BACK UP TO THE END CAUSING AIR IN THE LINE. NURSE STATES THEY USE NEXIVA DIFFUSICS 383590 (LOT# 9232125). THE NURSE WAS INSERTING THE DEVICE AND ONCE THE VEIN WAS ACCESSED ONLY A SMALL AMOUNT OF BLOOD FILLED THE TUBING. IT DID NOT BACK UP ALL THE WAY TO THE END AND THERE WAS AIR IN THE LINE. CALLER STATES THE PATIENT WAS VERY DEHYDRATED. THEY WENT AHEAD AND STARTED THE INFUSION AND WATCHED THE PATIENT AND NO ADVERSE REACTIONS WERE NOTED."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 24 GA 0.75 IN HAD AIR BUBBLES IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ONLY A SMALL AMOUNT OF BLOOD FILLED THE TUBING AND DID NOT BACK UP TO THE END CAUSING AIR IN THE LINE. NURSE STATES THEY USE NEXIVA DIFFUSICS 383590 (LOT#: 9232125). THE NURSE WAS INSERTING THE DEVICE AND ONCE THE VEIN WAS ACCESSED ONLY A SMALL AMOUNT OF BLOOD FILLED THE TUBING. IT DID NOT BACK UP ALL THE WAY TO THE END AND THERE WAS AIR IN THE LINE. CALLER STATES THE PATIENT WAS VERY DEHYDRATED. THEY WENT AHEAD AND STARTED THE INFUSION AND WATCHED THE PATIENT AND NO ADVERSE REACTIONS WERE NOTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334116 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 24 GA 0.75 IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9232125 00382903835904

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other