BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ CATHETER

    MDR report key: 16272464 · Received January 31, 2023

    Report

    Report Number
    9610048-2023-00002
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    February 21, 2022
    Report Date
    February 9, 2023
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 1111217, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE TIP OF THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING. THE DEVICE APPEARED TO HAVE BEEN USED AS MEDIA WAS PRESENT IN THE CATHETER AND THROUGHOUT THE FLASHBACK CHAMBER. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ CATHETER THE CATHETER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSING TECHNICIAN ENCOUNTERED RESISTANCE WHEN PULLING THE JELCO 24 TO REMOVE THE NEEDLE. WHEN HE WAS ABLE TO IDENTIFY THAT THE SILICONE CATHETER WAS BROKEN AND CAME OUT WITH THE NEEDLE,

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ CATHETER THE CATHETER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSING TECHNICIAN ENCOUNTERED RESISTANCE WHEN PULLING THE JELCO 24 TO REMOVE THE NEEDLE. WHEN HE WAS ABLE TO IDENTIFY THAT THE SILICONE CATHETER WAS BROKEN AND CAME OUT WITH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851173 BD INSYTE¿ AUTOGUARD¿ CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381812 1111217 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown