BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA¿

    MDR report key: 8265096 · Received January 21, 2019

    Report

    Report Number
    1710034-2019-00005
    Event Type
    Injury
    Date Received
    January 21, 2019
    Date of Event
    January 3, 2019
    Report Date
    February 22, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K102520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER: 8232654; THE LOT NUMBER WAS BUILT/PACKAGED ON NFA LINE 1 FROM 23AUG2018 THRU 26AUG2018 FOR A QUANTITY OF (B)(4) UNITS. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. CONCLUSION: INDETERMINATE ¿ WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THREE BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS HAD BROKEN WHILE BEING USED IN AN IV. THE CUSTOMER SAID "IN THE PAST 48 HOURS, WE HAVE HAD THREE SEPARATE NURSES REPORT THAT THE 18G NEXIVA IV'S CATHETER HAD "FALLEN OFF" WHILE ATTEMPTING TO PLACE AN I.V. THIS PRODUCT DEFECT RESULTED IN A DELAY OF PATIENT CARE IN ALL THREE PATIENT CASES.¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREE BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS HAD BROKEN WHILE BEING USED IN AN IV. THE CUSTOMER SAID "IN THE PAST 48 HOURS, WE HAVE HAD THREE SEPARATE NURSES REPORT THAT THE 18G NEXIVA IV'S CATHETER HAD "FALLEN OFF" WHILE ATTEMPTING TO PLACE AN I.V. THIS PRODUCT DEFECT RESULTED IN A DELAY OF PATIENT CARE IN ALL THREE PATIENT CASES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58494 BD NEXIVA¿ PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8232654 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other