BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 6815706 · Received August 23, 2017

    Report

    Report Number
    1710034-2017-00152
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    July 1, 2017
    Report Date
    October 6, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    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

    INVESTIGATION: DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 6181671. THE LOT NUMBER WAS BUILT ON AFA MANUFACTURING/PACKAGING LINE 11 FROM JULY 1, 2016 THRU JULY 6, 2017. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION S-AU17 IN ACCORDANCE WITH THE SET ¿UP AND IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. CONCLUSIONS: THE DEFECT OF PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE, STATED IN THE DESCRIPTION OF THE COMPLAINT, COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED AS THE UNITS DESCRIBED IN THE PRODUCT INCIDENT REPORT WERE NOT RETURNED FOR EVALUATION AND TESTING. THEREFORE, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. SAMPLES WERE NOT RETURNED FOR EVALUATION AND THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. DUE TO EVALUATION OF OTHER COMPLAINT SAMPLES, CAPA (B)(4) HAS BEEN OPENED TO INVESTIGATE THE PACKAGE OPEN SEAL DEFECTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PACKAGING ON A 20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS OPEN BEFORE USE. NO MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594663 20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6181671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other