BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 6080715 · Received November 4, 2016

    Report

    Report Number
    9610847-2016-00035
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    June 17, 2016
    Report Date
    June 26, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6060507. A MANUFACTURING REVIEW REVEALED THAT NO EQUIPMENT, INSTRUMENT, PROCESS, OR SURFACES COULD CAUSE THE TYPE OF DAMAGE REPORTED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, AN EMAIL FROM BD PERSONNEL WAS RECEIVED REPORTING THE PRODUCT COMPLAINT (ORIGINALLY REPORTED ON THE INITIAL MDR ON (B)(6) 2016). THE EMAIL CHAIN SHOWS THE ORIGINAL COMPLAINT WAS SUBMITTED TO THE BD PRIVACY DEPARTMENT ON (B)(6) 2016, HOWEVER, THIS INFORMATION WAS NOT SENT TO THE BD REGIONAL COMPLAINT CENTER UNTIL (B)(6) 2017. THEREFORE THE BD NOTIFICATION DATE HAS BEEN CHANGED FROM (B)(6) 2016. DATE RECEIVED BY MANUFACTURER: 6/22/2017.

    Description of Event or Problem · 1

    THERE WERE TWO SPECIFIC ISSUES REPORTED ASSOCIATED WITH A 20 G X 1 IN. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM. THE GUIDE WIRE BROKE OFF DURING REMOVAL AFTER SUCCESSFUL IV INSERTION (OCCURRED IN 22 AND 20 GAUGE IV CATHETERS). STAFF REPORT THAT WHEN REMOVING THE TROCAR, IT DOESN'T SHEATH INTO THE PROTECTIVE SLEEVE, LEAVING SHARPS EXPOSED. SPECIFIC DETAILS REGARDING THE NUMBER OF INCIDENTS OF EACH ISSUE AND WHICH IV CATHETER WAS USED IN EACH INCIDENT WERE NOT PROVIDED AND THE INITIAL REPORTER ONLY PROVIDED CATALOG AND LOT INFORMATION FOR THE 20 GAUGE DEVICE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730948 20 G X 1 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6060507

    Patients

    Seq Age Sex Outcome Treatment
    1 Other