BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN

    MDR report key: 16034712 · Received December 22, 2022

    Report

    Report Number
    1710034-2022-00849
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    December 1, 2022
    Report Date
    February 2, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835172
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE CATHETER ASSEMBLY FROM A 20GX1.25IN NEXIVA DEVICE, LOT NUMBER 2048021. IN ADDITION, FOUR PHOTOS WERE RECEIVED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT. MEDIA IS OBSERVED IN THE UNIT WHICH INDICATES USE. A GROSS VISUAL OF THE UNIT IDENTIFIED THAT THE SINGLE PORT LUER HAS BEEN DAMAGED. THE DAMAGE IS A DEFORMATION THAT RESULTED IN A WHOLE ON ONE SIDE OF THE LUER. THE UNIT WAS THEN LEAK TESTED WHERE AIR COULD BE HEARD ESCAPING THE LUER AT THE DAMAGE AREA. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO AN OPERATOR ERROR DURING A STATION CRASH CAUSING THE UNIT TO BE DAMAGED BY THE GRIPPERS OR PALLETS. OPERATORS PERFORMED TESTING FOR LEAKAGE PER THE SAMPLING PLAN. ADDITIONALLY, PALLETS ARE REPLACED, AND MAINTENANCE OF THE LINE AND EQUIPMENT IS PERFORMED PER THE QUALITY PLAN. THE PREVENTATIVE MAINTENANCE RECORD WAS CHECKED AND VERIFIED TO BE UP TO DATE DURING THE MANUFACTURING OF THIS LOT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN AIR WAS DRAWN INTO THE LINE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED AS FOLLOWS: AFTER PLACING THIS PRODUCT, THE HCP CONNECTED A SYRINGE TO THE CATHETER ADAPTER, AND AIR WAS DRAWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN AIR WAS DRAWN INTO THE LINE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED AS FOLLOWS: AFTER PLACING THIS PRODUCT, THE HCP CONNECTED A SYRINGE TO THE CATHETER ADAPTER, AND AIR WAS DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880843 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383517 2048021 30382903835172

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown