BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DUAL PORT 24GA 0.75IN (0.7 MM X 19 MM)

    MDR report key: 8418682 · Received March 13, 2019

    Report

    Report Number
    1710034-2019-00290
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    February 10, 2019
    Report Date
    April 23, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835318
    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

    THE FOLLOWING FIELD HAS BEEN UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD NEXIVA DUAL PORT 24GA 0.75IN (0.7 MM X 19 MM) EXPERIENCED SAFETY FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: VERBATIM: ¿WHEN ADVANCING THE CATHETER, THE PUSH TUB AND FINGER GLIP WERE STUCK BY SOMETHING LIKE GLUE.¿ H.6. INVESTIGATION: DURING DHR REVIEW 5 NON-RELATED QN¿S WERE INITIATED DURING PRODUCTION AND DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. ALL OTHER SET-UP, IN PROCESS AND CHALLENGE SAMPLES WERE PERFORMED PER SPECIFICATIONS. RECEIVED A 24GA NEXIVA UNIT WITHIN AN OPEN PACKAGE FROM LOT 8243975. ALL COMPONENTS WERE PRESENT. VISUAL/MICROSCOPIC EVALUATION: TRACES OF CURED ADHESIVE WAS OBSERVED ON THE TIP SHIELD AND ON THE GRIP. THE CURED ADHESIVE HAD GLUED TOGETHER THE TIP SHIELD AND THE GRIP PREVENTING SUCCESSFUL DISENGAGEMENT. PICTURES REVEALED SIMILAR FINDINGS THE FAILURE DESCRIBED IN THE INCIDENT REPORT WAS CAUSED WHEN CURED ADHESIVE ¿BONDED¿ THE TIP SHIELD AND THE GRIP PREVENTING THE UNIT FROM DISENGAGEMENT. THE CURED ADHESIVE WAS POTENTIALLY GENERATED BY A GRIPPER (SATURATED WITH GLUE) EITHER ON THE PALLETS OR THE MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA DUAL PORT 24GA 0.75IN (0.7 MM X 19 MM) EXPERIENCED SAFETY FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: VERBATIM: ¿WHEN ADVANCING THE CATHETER, THE PUSH TUB AND FINGER GLIP WERE STUCK BY SOMETHING LIKE GLUE.¿

    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 BD NEXIVA DUAL PORT 24GA 0.75IN (0.7 MM X 19 MM) EXPERIENCED SAFETY FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: VERBATIM: ¿WHEN ADVANCING THE CATHETER, THE PUSH TUB AND FINGER GLIP WERE STUCK BY SOMETHING LIKE GLUE.¿ SEE PR FOR ADDITIONAL DETAILS. COMPLAINT SUMMARY DETAIL: THIS IS MDR REPORTABLE. THE INCIDENT COULD HAVE POTENTIAL TO CAUSE HARM/SERIOUS INJURY, POSSIBLE BLOOD BORNE PATHOGEN EXPOSURE. EVENT TYPE: SAFETY FAILURE / MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208809 BD NEXIVA DUAL PORT 24GA 0.75IN (0.7 MM X 19 MM) INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8243975 30382903835318

    Patients

    Seq Age Sex Outcome Treatment
    1 Other