BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8151355 · Received December 11, 2018

    Report

    Report Number
    1710034-2018-00904
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 21, 2018
    Report Date
    January 10, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER 8232675; THE LOT NUMBER WAS BUILT ON AFA LINE 4 FROM 25AUG2018 THRU 30AUG2018. PACKAGED ON PACKAGING LINE 11 FROM 26AUG2018 THRU 30AUG2018 (PALLETS 1-7). PACKAGED ON PACKAGING LINE 9 FROM 30AUG2018 THRU 05SEPT2018 (PALLETS 8-11). REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. INDETERMINATE ¿ WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE TIP OF THE CATHETER STARTED TO SPLIT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE TIP OF THE CATHETER STARTED TO SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989924 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8232675 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other