BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8629217 · Received May 21, 2019

    Report

    Report Number
    1710034-2019-00537
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    April 15, 2019
    Report Date
    June 14, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818440
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER 8151967; THE LOT NUMBER WAS BUILT ON AFA LINE 8 FROM 05JUN18 THRU 09JUN18. PACKAGED ON PACKAGING LINE 11 FROM 10JUN18 THRU 11JUN18 FOR A QUANTITY OF (B)(4) UNITS. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. NO QNS WERE INITIATED ON THE BUILD OF THIS LOT NUMBER. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. CONCLUSION: 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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DID NOT ADVANCE WHILE CHANNELING, AND WAS FOUND BROKEN INTO A "FLOWER"-LIKE APPEARANCE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "AT THE TIME OF THE CHANNELING, IT DOES NOT ADVANCE AND THE CATHETER IS SEEN FLOWERED (FLOWER APPEARANCE)."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BD INSYTE AUTOGUARD SHIELDED IV CATHETER DID NOT ADVANCE WHILE CHANNELING, AND WAS FOUND BROKEN INTO A "FLOWER"-LIKE APPEARANCE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AT THE TIME OF THE CHANNELING, IT DOES NOT ADVANCE AND THE CATHETER IS SEEN FLOWERED (FLOWER APPEARANCE)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422850 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8151967 00382903818440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other