BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8619531 · Received May 17, 2019

    Report

    Report Number
    1710034-2019-00528
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 23, 2019
    Report Date
    July 12, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835318
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES PROVIDED. BD RECEIVED A TOTAL OF THREE 24GA NEXIVA UNITS. UNIT #1 WAS A 24GA CATHETER-ADAPTER ASSEMBLY CONNECTED TO A SALINE FILLED SYRINGE. UNIT #2 WAS ONLY A CATHETER-ADAPTER ASSEMBLY AND UNIT #3 WAS RECEIVED WITHIN A SEALED PACKAGE FROM LOT NUMBER 8230803, ALL CONTENTS WERE INTACT. A WATER-LEAK TEST WAS PERFORMED ON THE UNITS. LEAKAGE WAS OBSERVED WITH UNIT #1 AS THE CATHETER TUBING HAD A CUT-HOLE ABOVE THE NOSE OF THE ADAPTER. UNIT #2 REVEALED DAMAGE ON THE NOSE OF THE WINGED ADAPTER HOWEVER LEAKAGE WAS NOT CONFIRMED. THERE WAS NO PHYSICAL OR MECHANICAL DAMAGE FOUND ON UNIT #3. LEAKAGE WAS NOT OBSERVED. YOUR REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. THE DAMAGE OBSERVED ON THE NOSE OF THE WIND ADAPTER (UNITS 1 AND 2) APPEARS TO BE TRIGGERED BY THE MANUFACTURING PROCESS TYPICALLY DUE TO A STATION MISALIGNMENT OR GRIPPER MALFUNCTION CAUSING EXCESS FORCE ON THE SUPPORTING BLOCK, WHICH COULD CAUSE THE DAMAGE AS WELL AS THE SPEAR THROUGH. DHR WAS PERFORMED: A POTENTIALLY RELATED QN (B)(4) FOR AIR-WATER LEAK FAILURE WAS INITIATED DURING PRODUCTION ¿ DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED PER CONTROL PLAN.

    Description of Event or Problem · 0

    MATERIAL NO: 383531 BATCH NO: 9035541 IT WAS REPORTED THAT DURING USE OF THE BD NEXIVA DUAL PORT 24GA 0.75IN (0.7 MM X 19 MM) SALINE WAS LEAKING FROM THE CATHETER JUNCTION WHEN FLUSHING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN NOTICE SALINE LEAKING FROM THE CATHETER JUNCTION WHEN FLUSHING."

    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

    MATERIAL NO: 383531. BATCH NO: 9035541. IT WAS REPORTED THAT DURING USE OF THE BD NEXIVA DUAL PORT 24GA 0.75IN (0.7 MM X 19 MM) SALINE WAS LEAKING FROM THE CATHETER JUNCTION WHEN FLUSHING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN NOTICE SALINE LEAKING FROM THE CATHETER JUNCTION WHEN FLUSHING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415300 BD NEXIVA DUAL PORT 24GA 0.75IN (0.7 MM X 19 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9035541 30382903835318

    Patients

    Seq Age Sex Outcome Treatment
    1 Other