BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8616514 · Received May 16, 2019

    Report

    Report Number
    1710034-2019-00524
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835110
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE PROVIDED. BD RECEIVED TWO USED NEXIVA 24GA UNITS IN OPENED PACKAGES FROM CATALOG NUMBER 383511, LOT NUMBER 7235512. THROUGH THE VISUAL EXAMINATION, THE EXTENSION TUBING WAS SEPARATED FROM THE CLEAR PORT OF THE WINGED ADAPTER ON BOTH RETURNED UNITS. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS THE PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO AN INSUFFICIENT AMOUNT OF ADHESIVE DISPENSED IN THE TUBING/ADAPTER INSERTER PORT JOINT. CORRECTIVE ACTIONS, CAPA#684099, HAVE BEEN INITIATED TO MONITOR THE REPORTED ISSUE. DHR WAS PERFORMED AND ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. ONE QN WAS INITIATED ON THE BUILD OF THIS LOT THAT COULD IMPACT THE OUTCO OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM) EXPERIENCED TUBING SEPARATION FROM ADAPTOR/LUER CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511 BATCH NO.: 8235512 PER UF REPORT # 2201760000-2019-801: ON TWO SEPARATE OCCASIONS, THE RN INSERTED AN IV CATHETER ON A PATIENT AND BOTH TIMES WHEN THE NURSE WAS REMOVING THE STYLUS, THE TUBING BECAME DISCONNECTED FROM THE CLOSED SYSTEM, AND HAD TO BE REMOVED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (DATE) VIA MEDWATCH # (B)(4). DEVICE EVALUATED BY MFR: 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 TWO BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM) EXPERIENCED TUBING SEPARATION FROM ADAPTOR/LUER CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511, BATCH NO.: 8235512. PER UF REPORT # (B)(4): ON TWO SEPARATE OCCASIONS, THE RN INSERTED AN IV CATHETER ON A PATIENT AND BOTH TIMES WHEN THE NURSE WAS REMOVING THE STYLUS, THE TUBING BECAME DISCONNECTED FROM THE CLOSED SYSTEM, AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407818 BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM) INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8235512 30382903835110

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other