BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13423573 · Received February 2, 2022

    Report

    Report Number
    1710034-2022-00041
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 17, 2022
    Report Date
    January 25, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY A DEFECT WAS NOTICED AT THE TIP OF THE CATHETER. AT LEAST 15 PIECES WERE FOUND TO HAVE THIS DEFECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:382523 BATCH NO: 1172725   IT WAS REPORTED BY THE CONSUMER A RIDGE BULGING CLOSE TO THE TIP OF THE CATHETER. DETAIL: PATIENTS COMPLAINED OF PAIN AFTER IV INSERTION. AFTER CLOSER INSPECTION, THE NURSES NOTED A RIDGE/BULGING CLOSE TO THE TIP OF THE CATHETERS. APPROX 15 OR MORE CATHETERS WERE INSPECTED AFTER THE FACT, AND THE TEAM NOTED THE SAME RIDGE/BULGING. NUMBER OF OCCURRENCES: MULTIPLE; MORE THAN 15+.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY A DEFECT WAS NOTICED AT THE TIP OF THE CATHETER. AT LEAST 15 PIECES WERE FOUND TO HAVE THIS DEFECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:382523 BATCH NO: 1172725   IT WAS REPORTED BY THE CONSUMER A RIDGE BULGING CLOSE TO THE TIP OF THE CATHETER. DETAIL: PATIENTS COMPLAINED OF PAIN AFTER IV INSERTION. AFTER CLOSER INSPECTION, THE NURSES NOTED A RIDGE/BULGING CLOSE TO THE TIP OF THE CATHETERS. APPROX 15 OR MORE CATHETERS WERE INSPECTED AFTER THE FACT, AND THE TEAM NOTED THE SAME RIDGE/BULGING. NUMBER OF OCCURRENCES: MULTIPLE; MORE THAN 15+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112992 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 1172725 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown