BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8363263 · Received February 22, 2019

    Report

    Report Number
    1710034-2019-00206
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    February 1, 2019
    Report Date
    April 15, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835370
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE WERE MULTIPLE ADDITIONAL LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 8197833. D.4. MEDICAL DEVICE EXPIRATION DATE: 6/30/2021. H.4. DEVICE MANUFACTURE DATE: 7/16/2018. D.4. MEDICAL DEVICE LOT #: 8225544. D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2021. H.4. DEVICE MANUFACTURE DATE: 8/13/2018. H.6. INVESTIGATION SUMMARY: DHR REVIEWS WERE PERFORMED ON ALL POSSIBLE LOT NUMBERS. DHR REVIEW WAS PERFORMED ON LOT NUMBER 8172681; THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 1 FROM 26JUN18 THRU2-JUN18 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 NUMBER. DHR REVIEW WAS PERFORMED ON LOT NUMBER 8197833; THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE #1 FROM 17JULY2018 THRU 19JULY2018. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. DHR REVIEW WAS PERFORMED ON LOT NUMBER 8225544; THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 1 FROM 15AUG18 THRU 17AUG18 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 NUMBER. RECEIVED ONE USED NEXIVA 20GA UNIT FROM THE CATALOG NUMBER 383537; LOT NUMBER UNKNOWN. RECEIVED FOUR SUBMITTED PHOTOS FOR REVIEW: PHOTO ONE DISPLAYED A 20GA EXTENSION TUBING WRAPPED IN GAUZE AND SURGICAL TAPE WITH THE WINGED ADAPTER LOOSE. PHOTO TWO DISPLAYED VIEW OF THE PORT OF THE WINGED ADAPTER THAT THE EXTENSION TUBING WOULD BE ATTACHED TO. PHOTO THREE DISPLAYED THE END OF THE EXTENSION TUBING. PHOTO FOUR DISPLAYED FROM VIEW OF PHOTO THREE. VISUAL/MICROSCOPIC EVALUATION: THE EXTENSION TUBING WAS SEPARATED FROM THE CLEAR PORT OF THE WINGED ADAPTER. BASED ON THE EVALUATION OF THE SUBMITTED PHOTOS; THE PHOTOS DISPLAYED THE EXTENSION TUBING WAS SEPARATED FROM THE WINGED ADAPTER. WHICH IS THE SAME FINDING AS THAT OF THE EVALUATION OF THE RETURNED UNIT. PROBABLE ROOT CAUSE: MANUFACTURING ¿ THE DEFECT SEPARATION INSERTER FROM TUBING WAS IDENTIFIED AND CONFIRMED. THIS DEFECT WAS CREATED AT THE NEW ZONE 8 ADHESIVE DISPENSE STATION. WHEN THE ADHESIVE DISPENSES TIPS BECOME MISALIGNED, ADHESIVE IS NOT DISPENSED IN THE PROPER LOCATION LEADING TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE TUBING/ADAPTER PORT JOINT. THIS FAILURE MODE OF THE PROCESS WAS INTRODUCED BY THE NEW STATION DESIGN, AND THE 100% ADHESIVE PRESENCE VISION SYSTEM WAS NOT CAPABLE OF DETECTING THESE FAILURES. THE MANUFACTURING DEPARTMENT IDENTIFIED THE ISSUE AND TOOK IMMEDIATE CORRECTIVE ACTION ON (B)(6) 2018 BY UPGRADING THE VISION SYSTEM ON BOTH PRODUCTION LINES TO BE ABLE TO DETECT ADHESIVE THAT WAS NOT IN THE CORRECT LOCATION. HOLDERS FOR THE ADHESIVE DISPENSE TIPS WERE ADDED TO THE MACHINE ON (B)(6) 2018 TO BETTER PROTECT THE TIPS FROM DAMAGE AND BECOMING MISALIGNED. CAPA 684099 HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSION TUBE ON A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM DETACHED FROM THE WING AND BLOOD LEAKED OUT.

    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 THE EXTENSION TUBE ON A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM DETACHED FROM THE WING AND BLOOD LEAKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157591 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8172681 30382903835370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other