BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DIFFUSICS 22G X1.00 IN

    MDR report key: 19282302 · Received May 9, 2024

    Report

    Report Number
    9610847-2024-00119
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903836925
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383692 AND LOT NUMBER 3192383. 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. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. 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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    1.CAN YOU CONFIRM THAT THERE ARE ANY SERIOUS INJURIES THAT OCCUR TO THE PATIENT? IT WAS MENTIONED IN PIR WAS UNKNOWN. NO. 2. WHAT COURSE OF TREATMENT CHANGED DUE TO EVENT? IT WAS MENTIONED IN PIR WAS UNKNOWN. NEW CANNULA WAS INSERTED. 3.WHAT MEDICAL INTERVENTION OTHER THAN FIRST AID? IT WAS MENTIONED IN PIR WAS UNKNOWN. NEW CANNULA WAS INSERTED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X1.00 IN CATHETER WAS DEFECTIVE. PLASTIC TUBING ON NEXIVA BROKE OFF WHILE INJECTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546717 BD NEXIVA DIFFUSICS 22G X1.00 IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3192383 00382903836925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown