BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9167951 · Received October 8, 2019

    Report

    Report Number
    1710034-2019-01091
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    August 27, 2019
    Report Date
    October 18, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD UNIT FROM LOT: 9010578 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED NO PHYSICAL/MECHANICAL DAMAGE TO THE UNIT. THERE WERE NO HOLES OR CUTS TO THE CATHETER INDICATING THE NEEDLE PIERCING IT. FINALLY, A WATER/AIR LEAK TEST WAS PERFORMED TO DETERMINE IF THERE WERE ANY UNSEEN ISSUES AND NO LEAKAGE WAS OBSERVED. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE OBSERVED DURING INSPECTION THE ENGINEER WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HAD PIERCED THROUGH THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "SOFT NEEDLE HAS BEEN PIERCED".

    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 THE NEEDLE HAD PIERCED THROUGH THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BEFORE USE.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "SOFT NEEDLE HAS BEEN PIERCED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963830 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9010578 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other