BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DIFFUSICS W/MAXZERO 24G X 0.75 IN

    MDR report key: 21678456 · Received March 24, 2025

    Report

    Report Number
    9610847-2025-00064
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 14, 2025
    Report Date
    April 7, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903835959
    PMA / PMN Number
    K233529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383595 AND LOT NUMBER 4180763. 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. 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.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE ISSUE WAS IDENTIFIED AFTER USE. THE NURSES INSERTED THE IVS THEN BLOOD AND SALINE WAS RAPIDLY LEAKING OUT FROM WHERE THE CATHETER CONNECTED TO THE HUB OF THE IV. THIS DID RESULT IN THE IVS BEING REMOVED AND THE PEDIATRIC PATIENTS HAVING TO BE STUCK AGAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 24G X 0.75 IN CATHETER WAS DEFECTIVE / DAMAGED. IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER THAT HAS A HOLE RIGHT WHERE IT CONNECTS TO THE HUB. VERBATIM: HERE IS THE LOT NUMBER TO THE CATHETER THAT HAS A HOLE RIGHT WHERE IT CONNECTS TO THE HUB. THIS IS THE 3RD INSTANCE WE HAVE HEARD OF OVER THE LAST WEEK AND THERE COULD BE MORE THAT JUST HAVEN'T BEEN BROUGHT TO MY ATTENTION. I CAN'T SAY WITHOUT A DOUBT THAT THEY WERE ALL THE SAME LOT NUMBER, THIS IS THE ONLY PACKAGE THAT WAS SAVED FOR ME. ADDITIONAL INFORMATION: THE DATES OF THE INSTANCES WERE (B)(6) 2025. YES, THE MATERIAL NUMBER WAS 383595 ON THE TWO THAT WERE TURNED INTO ME. THE NURSES DID NOT SAVE THE CATHETER FROM THE FIRST INSTANCE, ONLY TOLD ME ABOUT IT AFTER IT HAD HAPPENED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768570 BD NEXIVA DIFFUSICS W/MAXZERO 24G X 0.75 IN INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4180763 00382903835959

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown