BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8545524 · Received April 24, 2019

    Report

    Report Number
    9610048-2019-00158
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 1, 2019
    Report Date
    August 31, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT. 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.

    Additional Manufacturer Narrative · 0

    D3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SANDY, UT. G1. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SANDY, UT. THE PRODUCT IS MADE IN SANDY, UT AND PACKAGED IN JUIZ DE FORA, BR. THIS REPORT ERRANTLY REPORTED THE MANUFACTURER AS JUIZ DE FORA, BR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE CATHETER RUPTURED. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: VENOUS PUNCTURE WAS PERFORMED WITH INSYTE N- AUTOGUARD 24G BD CATHETER, SHOWING QUALITY DEVIATION, DISTAL PORTION OF THE CATHETER RUPTURED CAUSING VESSEL TRANSFIXATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE CATHETER RUPTURED. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: VENOUS PUNCTURE WAS PERFORMED WITH INSYTE N- AUTOGUARD 24G BD CATHETER, SHOWING QUALITY DEVIATION, DISTAL PORTION OF THE CATHETER RUPTURED CAUSING VESSEL TRANSFIXATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (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 DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE CATHETER RUPTURED. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: VENOUS PUNCTURE WAS PERFORMED WITH INSYTE N- AUTOGUARD 24G BD CATHETER, SHOWING QUALITY DEVIATION, DISTAL PORTION OF THE CATHETER RUPTURED CAUSING VESSEL TRANSFIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335831 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8157504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other