BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7325960 · Received March 8, 2018

    Report

    Report Number
    2243072-2018-00138
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    January 21, 2018
    Report Date
    May 9, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K111366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FOR THE MEDICAL DEVICE LOT NUMBER(S), CATEGORY NUMBER (S), MANUFACTURING/EXPIRATION DATE(S), MANUFACTURING LOCATION. THE FOLLOWING FIELD(S) HAVE BEEN UPDATED: MEDICAL DEVICE BRAND NAME: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. MEDICAL DEVICE MANUFACTURER: NOGALES (DOUBLE CHECK WITH (B)(4). MEDICAL DEVICE LOT #: 7143594. MEDICAL DEVICE CAT #: 383551. UDI: (B)(4). MEDICAL DEVICE EXPIRATION DATE: 05/31/2020. MANUFACTURING LOCATION: NOGALES. 510K: K111366. DEVICE MANUFACTURE DATE: 07/06/2017.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS OCCURRENCE. DHR FOR LOT NUMBER 7143594 WAS REVIEWED AND NO QN RELATED TO THIS BATCH WERE DOCUMENTED, DURING THE DHR REVIEW WE VERIFIED THE QUALITY CONTROL PLAN FOR THE OPERATIONS AND NO ISSUES RELATED TO DEFECT MENTIONED BEFORE WERE DETECTED DURING MANUFACTURING OPERATION. THE MATERIAL 383551 WITH BATCH NUMBER MENTIONED BEFORE WAS MANUFACTURED ON JUNE 2017. BASED ON DHR REVIEW IT WAS CONFIRMED THAT THE QA TECHNICIAN PERFORMED THE SAMPLING PLAN ACCORDING OUR PROCEDURES WITHOUT ANY INCIDENTS, ADDITIONALLY ALL FUNCTIONAL TESTING AND PRODUCT PERFORMANCE MET SPECIFICATION CRITERIA, ACCEPTING AND RELEASING THIS LOT. ALL RELEVANT INFORMATION DURING THE DHR REVIEW SHOWN THAT MEET ALL ESTABLISHED MANUFACTURING CRITERIA. WITHOUT DEFECTIVE SAMPLE OR PHOTO WE COULD NOT DETERMINE THE EXACT ROOT CAUSE OF THE ISSUE. FOR THIS REASON WE WERE NOT ABLE TO ASSOCIATE THE REPORTED DEFECT TO THE MANUFACTURING PROCESS. NO CAPA WAS OPENED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT AND DATE RECEIVED CORRECTION. DATE OF EVENT: (B)(6) 2018. DATE RECEIVED BY MANUFACTURER: 01/24/2018.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE CORRECTION FOR MDR SUPPLEMENTAL #(B)(4).

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE UNSPECIFIED INTRAVASCULAR CATHETER ¿THE NEEDLE WAS UNABLE TO RETRACT FROM THE CATHETER SYSTEM, WITH THE ATTEMPT THE PRODUCT CAME APART AND ENTIRE NEEDLE WAS EXPOSED LEAVING THE RN AND PATIENT AT RISK OF NEEDLE POKE. PATIENT REQUIRED ADDITIONAL IV INSERTION ATTEMPT DUE TO PRODUCT FAILURE.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167982 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7143594

    Patients

    Seq Age Sex Outcome Treatment
    1 Other