BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA DIFFUSICS 24G X 0.75 IN

    MDR report key: 11675598 · Received April 15, 2021

    Report

    Report Number
    9610847-2021-00146
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903835904
    PMA / PMN Number
    K173354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY A COMPLAINT OF ISSUES FLUSHING WAS RECEIVED FROM THE CUSTOMER. A SAMPLE WAS RETURNED FOR FOR INVESTIGATION OF THIS DEFECT. DURING INSPECTION NO DEFECTS WERE SEEN ON THE SAMPLE. THROUGH TESTING, NO DEFECTS WERE OBSERVED ON THE SAMPLE EITHER. THE FAILURE COULD NOT BE REPLICATED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0112816. 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. A ROOT CAUSE COULD NOT BE DETERMINED AS THE FAILURE COULD NOT BE REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA DIFFUSICS 24G X 0.75 IN EXPERIENCED AN INCOMPLETE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(4) BATCH NO: 0112816 IT WAS REPORTED I HAD A LOT OF RESISTANCE AND COULD BARELY FLUSH THE CATHETER. VERBATIM: (B)(6) - TODAY I STARTED A 24 G DIFFUSICS ON A PATIENT AND EXPERIENCED A MALFUNCTION. THE CATHETER WENT IN SMOOTHLY AND I GOT GREAT BLOOD RETURN. I WAS ABLE TO COLLECT THE LABS NEEDED BUT AFTER A FEW MLS OF SALINE FLUSH, I HAD A LOT OF RESISTANCE AND COULD BARELY FLUSH THE CATHETER. I CHECKED THE SITE FOR INFILTRATION AND DID NOT SEE ANY SIGNS OF THAT. **** HELPED ME CHANGE THE CAP, SHE ALSO TRIED TO FLUSH AND THERE WAS STILL TOO MUCH RESISTANCE. THE PATIENT DENIED ANY PAIN WITH THE FLUSH. I DISCONTINUED THE IV AND ATTEMPTED TO FLUSH THE CATHETER WITH SALINE AFTER IT WAS OUT BUT COULD NOT. THIS CONFIRMED THAT IT WAS AN ISSUE WITH THE CATHETER AND NOT THE PLACEMENT IN THE VEIN. I SAVED THE CATHETER AND THE PACKAGE INFORMATION.

    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 NEXIVA DIFFUSICS 24G X 0.75 IN EXPERIENCED AN INCOMPLETE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383590 BATCH NO: 0112816. IT WAS REPORTED I HAD A LOT OF RESISTANCE AND COULD BARELY FLUSH THE CATHETER. ON (B)(6) TODAY I STARTED A 24 G DIFFUSICS ON A PATIENT AND EXPERIENCED A MALFUNCTION. THE CATHETER WENT IN SMOOTHLY AND I GOT GREAT BLOOD RETURN. I WAS ABLE TO COLLECT THE LABS NEEDED BUT AFTER A FEW MLS OF SALINE FLUSH, I HAD A LOT OF RESISTANCE AND COULD BARELY FLUSH THE CATHETER. I CHECKED THE SITE FOR INFILTRATION AND DID NOT SEE ANY SIGNS OF THAT. HELPED ME CHANGE THE CAP, SHE ALSO TRIED TO FLUSH AND THERE WAS STILL TOO MUCH RESISTANCE. THE PATIENT DENIED ANY PAIN WITH THE FLUSH. I DISCONTINUED THE IV AND ATTEMPTED TO FLUSH THE CATHETER WITH SALINE AFTER IT WAS OUT BUT COULD NOT. THIS CONFIRMED THAT IT WAS AN ISSUE WITH THE CATHETER AND NOT THE PLACEMENT IN THE VEIN. I SAVED THE CATHETER AND THE PACKAGE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566592 NEXIVA DIFFUSICS 24G X 0.75 IN INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0112816 00382903835904

    Patients

    Seq Age Sex Outcome Treatment
    1