BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA

    MDR report key: 16782304 · Received April 20, 2023

    Report

    Report Number
    1710034-2023-00435
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 31, 2023
    Report Date
    May 19, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 13-APR-2023 . H6: INVESTIGATION SUMMARY: BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD DEVICE FROM LOT 2110374 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 THAT THE BARREL HAD MEDIA PRESENT INSIDE INDICATING USE. THE NEEDLE APPEARED TO BE RETRACTED INTO THE BARREL. NEXT, THE UNIT WAS INSPECTED UNDER A MICROSCOPE AND THE ENGINEER NOTICED A HOLE IN THE CATHETER AND A V-SHAPED CUT IN THE TUBING INDICATING THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING. FINALLY, THREE PHOTOS OF THE DEFECT WERE PROVIDED FOR INSPECTION AND THE ENGINEER OBSERVED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING RIGHT WHERE THE OBSERVED CUT WAS FOUND IN THE RETURNED UNIT. THEREFORE, BASED OFF THE PROVIDED PHOTOS AND VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, THE ENGINEER WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE OBSERVED DAMAGE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE NEEDLE PIERCED THE CATHETER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER ISSUE WITH THE 22 GAUGE BD ANGIOCATH, BD # 381423, MCK # 330000. THE NEEDLE WENT THROUGH THE SIDE OF THE PLASTIC SHEATH. LOT # 2110374. THIS HAS ONLY HAPPENED ONCE AND THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE NEEDLE PIERCED THE CATHETER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER ISSUE WITH THE 22 GAUGE BD ANGIOCATH, BD # 381423, MCK # 330000. THE NEEDLE WENT THROUGH THE SIDE OF THE PLASTIC SHEATH. LOT # 2110374. THIS HAS ONLY HAPPENED ONCE AND THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866666 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 2110374 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown