BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8034185 · Received November 2, 2018

    Report

    Report Number
    1710034-2018-00787
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 17, 2018
    Report Date
    January 8, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835172
    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

    H.6. INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER 8142584; THE LOT NUMBER WAS BUILT / PACKAGED NFA LINE 1 FROM MAY 25, 2018 THRU MAY 30, 2018. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED THREE NON-RELATED QNS WERE INITIATED DURING THE BUILD OF THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. RECEIVED ONE USED NEXIVA 20GA CATHETER ADAPTER/EXTENSION SET, THE NEEDLE SET ASSEMBLY AND AN OPENED PACKAGE FROM THE CATALOG NUMBER 383517, LOT NUMBER 8142584. THE STRAIGHT ADAPTER WAS ATTACHED TO AN EXTENSION SET AND SYRINGE AS WELL AS A SECOND SYRINGE. 11 PHOTOS WERE SUBMITTED FOR REVIEW. VISUAL/MICROSCOPIC EVALUATION: SEPTUM SLIT CUT WAS OFF CENTER DAMAGE ON THE INSIDE OF THE TIP SHIELD THE NEEDLE SET TO THE OUT POSITION; THE NEEDLE WAS THEN DISENGAGED. GRINDING WAS FELT HAS THE NEEDLE WOULD SLIDE THROUGH THE DAMAGED AREA BASED ON THE REVIEW OF THE SUBMITTED PHOTOS THE DEFECT OTHER WAS CONFIRMED. THE PHOTO THREE DISPLAYED THE DAMAGED ON THE INSIDE OF THE TIP SHIELD. INVESTIGATION CONCLUSION: MANUFACTURING ¿ THE NEEDLE WAS INSERTED THROUGH THE SEPTUM AT AN ANGLE; WHICH ALLOWED THE NEEDLE TO CAUSE THE DAMAGED ON THE INSIDE OF THE TIP SHIELD. ZONE 4 STATION 40 OR STATION 62 WAS OUT OF "ALIGNMENT".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD A CRACKED CAP AND WAS DIFFICULT TO OPERATE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD A CRACKED CAP AND WAS DIFFICULT TO OPERATE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875650 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8142584 30382903835172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other