BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NSYTE AUTOGUARD WINGED

    MDR report key: 18972036 · Received March 25, 2024

    Report

    Report Number
    1710034-2024-00230
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 1, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815128
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381512 AND LOT NUMBER 3292288. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    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. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NSYTE AUTOGUARD WINGED CATHETER TIP INTEGRITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITH THE NEW SUBS FOR THE IV CATHETERS LYN HAS HAD THE NEEDLE GO THROUGH THE SMALL SHEATH ON TWO DIFFERENT DEVICES. IT MAY HAVE BEEN CRACKED AS SHE DID NOT PULL THE NEEDLE BACK AND REINSERT. NOT SURE IF THIS HAS BEEN REPORTED FROM ANY OTHER AREAS BUT WE WANTED TO GET THAT TO SUPPLY CHAIN TO MAKE SURE IT WAS RECOGNIZED. I TALKED TO AMBER SHE SAID THE CATHETER SHEARED ON TWO SEPARATE IV'S WITH THE SAME RN HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? BOTH PATIENTS NEEDED SECOND ATTEMPT AT IV. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15335 BD NSYTE AUTOGUARD WINGED PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3292288 00382903815128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown