BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7603117 · Received June 14, 2018

    Report

    Report Number
    1710034-2018-00334
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 25, 2018
    Report Date
    August 16, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW SHOWS THE LOT WAS BUILT AND PACKAGED ON NFA LINE 1 FROM 15AUG17 THROUGH 17AUG17 FOR THE QUANTITY OF 181,450EA. ALL REQUIRED CHALLENGE, SET UP AND IN PROCESS SAMPLES WERE PERFORMED ACCORDING TO THE QUALITY PLAN AND ALL PASSED PER SPECIFICATIONS. ONE NON RELATED QN (200704463 ¿ SUSPECT OCCLUDED CANNULA) WAS INITIATED AND DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. END USER RISK ANALYSIS (EURA) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. OBSERVATIONS AND TESTING: RECEIVED 1 NEXIVA 18GA USED UNIT WITHIN A SPECIMEN BOTTLE WITH A PIECE OF TOP WEB (PACKAGING) FROM LOT NUMBER 7223595. THE UNIT HAD TRACES OF BLOOD THROUGHOUT ITS COMPONENTS. SIMULATION TEST (DISENGAGEMENT): SIMULATION TEST IN AN ATTEMPT TO RECREATE THE CUSTOMER¿S EXPERIENCE. THE UNIT SUCCESSFULLY DISENGAGED AND THE ADAPTER WAS RELEASED WITHOUT RESISTANCE, THE NEEDLE WAS NOT BENT AND NO SIGNS OF ADHESIVE OR PHYSICAL-MECHANICAL DAMAGE WAS FOUND ON ANY OF THE COMPONENTS OF THE UNIT. ROOT CAUSE FOR TO THE REPORTED INCIDENT IS INDETERMINATE. THE FAILURE DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR RECREATED IN THE LABORATORY. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS FOUND WITH DIFFICULT NEEDLE DISENGAGEMENT AS "A NEXIVA CATHETER WAS USED BY AN EMERGENCY DEPARTMENT NURSE AND THE NEEDLE WOULD NOT COME OUT. THE PATIENT HAD TO BE STUCK AGAIN. " THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    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 DURING USE A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS FOUND WITH DIFFICULT NEEDLE DISENGAGEMENT AS "A NEXIVA CATHETER WAS USED BY AN ED NURSE AND THE NEEDLE WOULD NOT COME OUT. THE PATIENT HAD TO BE STUCK AGAIN. " THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442045 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7223595 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other