BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL

    MDR report key: 17234769 · Received June 29, 2023

    Report

    Report Number
    1710034-2023-00751
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    April 26, 2023
    Report Date
    July 31, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.4. FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH# (B)(4). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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: 18JUL2023. H6: INVESTIGATION SUMMARY: BD RECEIVED THREE INSYTE AUTOGUARD BLOOD CONTROL UNITS FROM LOTS 3061023, 3076650, AND 2349100 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THE REPORTED LOTS AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED THAT THE FIRST UNIT WAS FROM LOT 3076650. IT APPEARED TO ONLY BE A CATHETER ASSEMBLY AND PACKAGING. THE ENGINEER MICROSCOPICALLY INSPECTED THE UNIT AND OBSERVED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING NEAR THE TIP. THE SECOND UNIT WAS DETERMINED TO BE FROM LOT 3061023 AND DID NOT HAVE ANY BLOOD RESIDUE INDICATING VENIPUNCTURE. THE NEEDLE ALSO APPEARED TO HAVE PIERCED THROUGH THE CATHETER TUBING AT THE TIP. THE THIRD UNIT WAS FROM LOT 2349100. THIS UNIT WAS ALREADY RETRACTED INSIDE OF THE BARREL AND NO DAMAGE WAS OBSERVED TO THE UNIT. THE ENGINEER RESET THE UNIT BUT NO DEFECTS WERE FOUND TO THE UNIT. THEREFORE, BASED OFF THE VISUAL INSPECTION OF THE FIRST TWO UNITS THE ENGINEER WAS ABLE TO VERIFY THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING. UNFORTUNATELY, THE ENGINEER WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THESE ISSUES. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    T WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL THE TIP WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: THE ISSUE WAS THE CATHETERS WERE FRAYING ON THE ENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL THE TIP WAS DAMAGED. THIS OCCURRED 8 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: THE ISSUE WAS THE CATHETERS WERE FRAYING ON THE ENDS. CUSTOMER DISPOSITION REQUEST: REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823530 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382533 2349100 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown