BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7974495 · Received October 17, 2018

    Report

    Report Number
    1710034-2018-00736
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 27, 2018
    Report Date
    December 6, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW WAS PERFORMED ON LOT NUMBER 8138633; THE LOT NUMBER WAS BUILT/PACKAGE ON NFA LINE 2 FROM (B)(6) 2018 THRU (B)(6) 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 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. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. ONE PHOTO WAS SUBMITTED FOR REVIEW. CONCLUSION(S): THE PROVIDED PHOTO DISPLAYED THE PAPER TOP WEB (LABEL) WHICH IDENTIFIED THE PRODUCT AS REF (B)(4), LOT 6042943, EXPIRATION DATE 2019-01-31. 22GA UNIT WITH BODILY FLUIDS IN THE CATHETER TUBING, BETWEEN THE WEDGE AND PRIMARY SEPTUM, TWO DROPS IN THE EXTENSION TUBING AND THE END OF THE GREY CANISTER. THE DEFECTS; BLOOD BACKS UP/NOT COMPLETELY EXPELLED/LEAKAGE/BLOOD EXCESS/SPLASH/SPILL/SXPOSURE WERE NOT CONFIRMED BASED ON THE SUBMITTED PHOTO INDETERMINATE ¿ THE PHOTO PROVIDED DID NOT PROVIDE ENOUGH EVIDENCE TO DETERMINE IF THE UNIT DID OR DID NOT MEET SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA CLOSED IV CATHETER SYSTEM LEAKED. 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 LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817128 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8138633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other