BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT

    MDR report key: 19503696 · Received June 10, 2024

    Report

    Report Number
    1710034-2024-00543
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 16, 2024
    Report Date
    July 16, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835171
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. D. THE LOT NUMBER 3432046 PROVIDED CANNOT BE VERIFIED IN ASSOCIATION WITH THE REPORTED MATERIAL NUMBER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. TWO PHOTOGRAPHS AND ONE VIDEO WERE PROVIDED FOR INVESTIGATION. ONE PHOTO SHOWED A 20G NEXIVA DEVICE WITHOUT THE NEEDLE THAT WAS INSERTED IN THE PATIENT'S ARM. WHAT APPEARED TO BE BLOOD RESIDUE WAS OBSERVED IN THE CATHETER TUBING AND CATHETER ADAPTER. IT APPEARED THAT BLOOD BYPASSED THE SEPTUM AND LEAKED FROM THE CATHETER ADAPTER. TWO COTTON SWABS WERE SHOWN WITH RED STAINS ON THE WHITE SWAB. THE OTHER PHOTO SHOWED THE DECOUPLED NEEDLE WITH THE NEEDLE TIP SHIELDED. THE NEEDLE WAS PLACED OVER THE TOP WEB LABEL WITH REF #383517 AND WHAT APPEARED TO BE LOT #3234046. THE VIDEO SHOWED FLUID BYPASSING THE SEPTUM AND LEAKING FROM THE CATHETER ADAPTER. BASED ON THE LOCATION AND APPEARANCE OF THE LEAK OUR ENGINEERS HAVE DETERMINED THE MOST LIKELY ROOT CAUSE TO BE RELATED TO THE MANUFACTURING PROCESS. THIS WAS THE PHYSICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO A MISALIGNMENT IN THE AUTOMATED SEPTUM ASSEMBLY STATION. 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 THAT BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AFTER SUCCESSFUL PUNCTURE, BLOOD SEEPS OUT FROM THE BACK SEAT OF THE NEEDLE. WHEN PUSHING THE SYRINGE, BLOOD SPURTS OUT FROM THE BACK SEAT OF THE NEEDLE. THE DEFECTIVE PRODUCT CANNOT BE RETURNED. THERE ARE PICTURES. CLAIMS ARE REQUIRED. A COMPLAINT REPLY LETTER IS REQUIRED, BUT A COMPLAINT RECEIPT LETTER IS NOT REQUIRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8715 BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234046 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown