BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ PERIPHERAL INTRAVENOUS CATHETER

    MDR report key: 15089020 · Received July 22, 2022

    Report

    Report Number
    9610048-2022-00072
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 22, 2022
    Report Date
    September 19, 2022
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    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

    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

    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, 132746, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING. THEREFORE, BASED OFF THE PROVIDED PHOTOS THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE APPEARED TO HAVE BEEN USED. THIS TYPE OF DEFECT CAN OCCUR DURING THE CATHETER PLACEMENT PROCESS OR DURING THE PROCESS OF BREAKING TIP ADHESION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD INSYTE¿ AUTOGUARD¿ PERIPHERAL INTRAVENOUS CATHETER CALIBER IS TEARING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: CUSTOMER REPORTS THAT IAG 22G CALIBER IS TEARING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD INSYTE¿ AUTOGUARD¿ PERIPHERAL INTRAVENOUS CATHETER CALIBER IS TEARING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: CUSTOMER REPORTS THAT IAG 22G CALIBER IS TEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608094 BD INSYTE¿ AUTOGUARD¿ PERIPHERAL INTRAVENOUS CATHETER CATHETER, INTRAVASCULAR FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381823 0132746 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown