BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7757672 · Received August 7, 2018

    Report

    Report Number
    3006948883-2018-00142
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    July 13, 2018
    Report Date
    September 26, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INTIMA-II CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE SEPTUM. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7047028 MEDICAL DEVICE EXPIRATION DATE: 2020-02-29 DEVICE MANUFACTURE DATE: 2017-02-16 ; MEDICAL DEVICE LOT #: 7234037 MEDICAL DEVICE EXPIRATION DATE: 2020-10-06 DEVICE MANUFACTURE DATE: 2017-08-22. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    SAMPLES AND PHOTOGRAPHS WERE RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION. THE INVESTIGATORS WERE ABLE TO OBSERVE THE REPORTED FAILURE MODE IN THE SAMPLE PROVIDED. THE BATCH RECORDS FOR LOT#7047028, AND 7234037 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND DURING THE MANUFACTURING PROCESS. THE MOST PROBABLE ROOT CAUSE FOR THIS IS AN AGED SEPTUM THAT WAS ALTERED DUE TO CONTACT WITH HEAT FROM SUNLIGHT DURING TRANSPORTATION OF THE DEVICE DURING SUMMER MONTHS. BD HAS NOTIFIED THE SHIPPING COMPANY AND REQUESTED THAT THIS DEVICE ONLY BE SHIPPED IN INSULATED CONTAINERS. BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. (B)(4) HAS BEEN OPENED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE SEPTUM. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INTIMA-II CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE SEPTUM. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601221 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O