BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 7131832 · Received December 19, 2017

    Report

    Report Number
    9610847-2017-00202
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 28, 2017
    Report Date
    February 8, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND CONFIRMED THAT THE NEEDLE HAD BEEN COMPLETELY ACTIVATED AND SHIELDED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 6243927. WE CANNOT CONFIRM OR ASSOCIATE THE REPORTED DEFECT TO BE ASSOCIATED WITH THE MANUFACTURING PROCESS WITH THE PROVIDED INFORMATION. WE RECEIVED ONLY A COMPLETE ACTIVATED SAFETY DEVICE. THIS REPORTED DEFECT COULD BE RELATED WITH AN INCORRECT USE OF THE PRODUCT BY USER AND A POSSIBLE CAUSE IS THAT AFTER OF FINISHING THE PUNCTURE, USER PERFORMED THE ACTIVATION SINCE ADAPTER STI PRN WAS REMOVING ALL THE SAFETY MECHANISMS AND LEAVING EXPOSED CANNULA. CONCLUSION: BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE FOR MANUFACTURING PROCESS CANNOT BE DETERMINED, HOWEVER A POSSIBLE CAUSE COULD BE THE USE INCORRECT OF THE DEVICE BY USER. NO CAPA WAS OPENED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA OCTOBER 2017 VIA MEDWATCH # (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. -

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY OF A BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM DID NOT ENGAGE AFTER USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911560 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6243927 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other