BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE 20GA X 1.16IN

    MDR report key: 12927667 · Received December 3, 2021

    Report

    Report Number
    9610048-2021-00161
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    October 29, 2021
    Report Date
    December 29, 2021
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. H3 OTHER TEXT : SEE H.10.

    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 THAT BD INSYTE 20GA X 1.16IN WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " EVENT 2: PERIPHERAL VENOUS CATHETER # 20 WAS REQUESTED FOR CANNULATION, AT THE MOMENT THE PATIENT IS PUNCTURED, RETURN IS EVIDENT, THE CATHETER IS ADVANCED AND IT IS EVIDENCED THAT THE CATHETER BLOOMS IN THE MIDDLE AND THIS IMPLIES A NEW PUNCTURE OF THE PATIENT. PATIENT DIAGNOSIS: RENAL FAILURE, SEX: FEMALE, AGE: 30 YEARS. CATALOG 38831414, LOT 1131191. DATE OF THE EVENT: (B)(6) 2021."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE 20GA X 1.16IN WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " EVENT 2: PERIPHERAL VENOUS CATHETER # 20 WAS REQUESTED FOR CANNULATION, AT THE MOMENT THE PATIENT IS PUNCTURED, RETURN IS EVIDENT, THE CATHETER IS ADVANCED AND IT IS EVIDENCED THAT THE CATHETER BLOOMS IN THE MIDDLE AND THIS IMPLIES A NEW PUNCTURE OF THE PATIENT. PATIENT DIAGNOSIS: RENAL FAILURE, SEX: FEMALE, AGE: 30 YEARS. CATALOG 38831414, LOT 1131191. DATE OF THE EVENT: (B)(6) 2021."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820230 BD INSYTE 20GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 1131191

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female