BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 20GA 1.25IN HF Y W/ CAP

    MDR report key: 13581699 · Received February 22, 2022

    Report

    Report Number
    1710034-2022-00088
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 5, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 04-MAR-2022. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE 20GA BD NEXIVA CLOSED IV CATHETER SYSTEM-DUAL PORT IN TWO PORTIONS. PORTION ONE CONSISTS OF THE CATHETER ADAPTER AND EXTENSION LINE ASSEMBLIES THAT IS WITH THE PINCH CLAMP FULLY ENGAGED AND HAS THE VENT PLUG AT ONE LUER PORT AND A Q-SYTE AT THE SECOND LUER PORT. THERE ARE TRACES OF THICK MEDIA THROUGHOUT THE ENTIRE PORTION. PORTION TWO IS THE NEEDLE GRIP ASSEMBLY FULLY PULLED BACK WITH THE TIP SECURED INSIDE THE TIP SHIELD. ACCOMPANYING THE PORTIONS IS A TOP WEB (LABEL) IDENTIFYING THE PRODUCT AS REFERENCE NUMBER 383647, LOT NUMBER 0112055. THROUGH THE VISUAL OBSERVATION NO DAMAGE TO THE RETENTION WASHER WAS FOUND THAT COULD CONTRIBUTE TO DIFFICULTY DURING DISENGAGEMENT. THE V-CLIP SHOWS TO HAVE SOME SCUFF MARKINGS, WHICH IS COMMONLY SEEN AS PART OF THE ASSEMBLY AND IS CONSIDERED COSMETIC. DEFORMITY AND DAMAGE WERE OBSERVED TO THE TIP SHIELD AND TO THE AREA OF THE FINGER GRIP. FUNCTIONAL TESTING OF NEEDLE RETRACTION WAS PERFORMED. THE NEEDLE DEMONSTRATED TO BE SLIGHTLY TIGHT WHILE POSITIONING THE NEEDLE TO PLACE IT TO THE OUT POSITION. DRAG AND RESISTANCE IS NOT EXPERIENCED WHILE PUSHING THE NEEDLE BACK OUT THROUGH THE WASHER OR DURING NEEDLE DISENGAGEMENT WHEN PULLING THE NEEDLE BACK THROUGH THE WASHER INTO THE TIP SHIELD. IT IS ALSO VISIBLE THAT THE RETENTION WASHER IS MOVING AND FLOATING FREELY, AS INTENDED TO DURING DISENGAGEMENT. THERE WERE NO ABNORMALITIES OR DAMAGE OBSERVED TO THE NEEDLE. THE UNIT WAS THEN DISSECTED, AND OBSERVATION OF THE WASHER REVEALS NO ABNORMALITIES OR DAMAGE. BASED ON THE DAMAGE OBSERVED TO THE TIP SHIELD AND GRIP AND THE SLIGHT TIGHTNESS OF THE NEEDLE WHEN POSITIONING FOR FUNCTIONAL TESTING, IT IS PLAUSIBLE THAT ORIGINALLY THE CLINICIAN EXPERIENCED DIFFICULT NEEDLE DISENGAGEMENT, LIKELY CAUSED BY THE DAMAGE TO THE TIP SHIELD. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO GRIPPER DAMAGE/WEAR OR MISALIGNMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD NEXIVA 20GA 1.25IN HF Y W/ CAP, THE USER IDENTIFIED A PROBLEM WITH THE SAFETY MECHANISM NOT ENGAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WHEN THE KT WAS PLACED, IT WAS IMPOSSIBLE TO REMOVE THE METAL MANDREL, SO SHE HAD TO REMOVE THE MATERIAL AND PUT THE PATIENT BACK IN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD NEXIVA 20GA 1.25IN HF Y W/ CAP, THE USER IDENTIFIED A PROBLEM WITH THE SAFETY MECHANISM NOT ENGAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WHEN THE KT WAS PLACED, IT WAS IMPOSSIBLE TO REMOVE THE METAL MANDREL, SO SHE HAD TO REMOVE THE MATERIAL AND PUT THE PATIENT BACK IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686352 BD NEXIVA 20GA 1.25IN HF Y W/ CAP INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0112055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown