BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7367783 · Received March 23, 2018

    Report

    Report Number
    1710034-2018-00135
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    March 16, 2018
    Report Date
    May 7, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835325
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE VIDEO AND FIVE PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION OF THE VIDEO, LEAKAGE WAS OBSERVED FROM THE TOP OF THE Q-SYTE SEPTUM. THE PICTURES REVEALED A Q-SYTE UNIT WITH AN EXCESSIVE AMOUNT OF BODILY FLUIDS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE LOT NUMBER PROVIDED THAT COULD HAVE CONTRIBUTED TO THE OBSERVED DEFECT. DHR REVIEW WAS PERFORMED ON THE FOLLOWING SUB ASSEMBLY PART NUMBERS AND LOT NUMBERS: 8004149 (BD Q-SYTE ASSEMBLY): 7174853 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 1, FROM JUNE 25, 2017 THRU JUNE 27, 2017. 7174856 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 1, FROM JUNE 27, 2017 THRU JUNE 30, 2017. 7174857 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 1, FROM JUNE 30, 2017 THRU JULY 3, 2017. 7191501 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 4, FROM JULY 16, 2017 THRU JULY 18, 2017. 8001498 (BD Q-SYTE ASSEMBLY WITH CAP) 7160904 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 4, FROM JUNE 27, 2017 THRU JUNE 29, 2017. 7160905 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 4, FROM JUNE 29, 2017 THRU JULY 1, 2017. 7160892 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM JUNE 29, 2017 THRU JUNE 30, 2017. 7174873 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 4, FROM JULY 2, 2017 THRU JULY 6, 2017. 7191504 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 4, FROM JUNE 29, 2017 THRU JULY 1, 2017. 7191547 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 4, FROM JULY 30, 2017 THRU AUGUST 1, 2017. REVIEW OF THE DHRS REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. OBSERVATIONS AND TESTING: ALTHOUGH OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION, THERE WERE FIVE PHOTOS AND ONE VIDEO WERE SUBMITTED FOR REVIEW. THE VIDEO WAS REVIEW AND CONFIRMED THE LEAKAGE COMING FROM THE TOP OF THE SEPTUM OF THE Q-SYTE UNIT. PHOTO ONE DISPLAYED A Q-SYTE UNIT INSIDE OF A PACKAGE. THE Q-SYTE HAD AN EXCESSIVE AMOUNT OF BODILY FLUIDS. PHOTO TWO DISPLAYED AN UP-CLOSE Q-SYTE UNIT INSIDE OF A PACKAGE. PHOTO THREE DISPLAYED A Q-SYTE UNIT INSIDE OF A PACKAGE. PHOTO FOUR DISPLAYED AN UP-CLOSE PHOTO OF THE Q-SYTE UNIT. PHOTO FIVE DISPLAYED A Q-SYTE UNIT INSIDE OF A PACKAGE ALONG WITH A NOTE. WITHOUT THE PHYSICAL SAMPLE AVAILABLE FOR TESTING AND FURTHER EVALUATION, A DEFINITE CAUSE FOR THE LEAKAGE COULD NOT BE DETERMINED. THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. Q-SYTE PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS TO ENSURE PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED MONTHLY. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE OF 07/31/2020 HAS BEED UPDATED.

    Additional Manufacturer Narrative · 1

    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 DURING USE A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS FOUND LEAKING NACL FLUID AS ¿Q-SYTE IS LEAKING AT THE FRONT. ¿THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207739 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7219985 30382903835325

    Patients

    Seq Age Sex Outcome Treatment
    1 Other