BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN

    MDR report key: 11780993 · Received May 5, 2021

    Report

    Report Number
    1710034-2021-00377
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 8, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903833239
    PMA / PMN Number
    K923702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0233515. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED AND THEREFOR THE FAILURE WAS NOT CONFIRMED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN EXPERIENCED A SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE STYLET DID NOT ENGAGE IN THE SAFETY MECHANISM. VERBATIM: WE HAD AN INCIDENT ON Y2 TODAY WITH AN INTIMA IV (PLEASE SEE ACTUAL DESCRIPTION PER SAFETY REPORT BELOW):¿".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER 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 · 1

    IT WAS REPORTED THAT A SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN EXPERIENCED A SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE STYLET DID NOT ENGAGE IN THE SAFETY MECHANISM. VERBATIM: WE HAD AN INCIDENT ON Y2 TODAY WITH AN INTIMA IV (PLEASE SEE ACTUAL DESCRIPTION PER SAFETY REPORT BELOW)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674796 SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383323 0233515 30382903833239

    Patients

    Seq Age Sex Outcome Treatment
    1