BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6988085 · Received October 30, 2017

    Report

    Report Number
    1710034-2017-00280
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    September 11, 2017
    Report Date
    January 8, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THE ROOT CAUSE IS INDETERMINATE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (DATE) VIA MEDWATCH # 5072257 19-SEP-2017. PER MEDWATCH REPORT, DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THERE IS NO CUSTOMER CONTACT INFORMATION LISTED ON THE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMALE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (B)(6) 2017 AT 1334. WHILE OBTAINING A PATENT IV USING THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE PATIENT STATED SHE FELT A POP WITHIN THE VEIN. WHILE SHOWERING THE PATIENT REPORTED A DISLODGED IV AND THE CATHETER WAS NOT FOUND. (PATIENT THOUGHT THE CATHETER REMAINED IN THE VEIN) THE NURSE NOTIFIED THE PHYSICIAN OF THE PATIENTS CONCERNS. THIS MDR IS REPORTED AS A SERIOUS INJURY HOWEVER, NO MEDICAL INTERVENTION WAS NOTED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767314 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVENOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7089529 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other