BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN

    MDR report key: 13197581 · Received January 7, 2022

    Report

    Report Number
    2243072-2021-03064
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 13, 2021
    Report Date
    March 7, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. (SANDY) D.4. MEDICAL DEVICE LOT #: 9049997 D.4. MEDICAL DEVICE EXPIRATION DATE: 1/31/2023 H.4. DEVICE MANUFACTURE DATE: 3/1/2019 D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 2/21/2022 G.1. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. (SANDY) H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE 2 SAMPLES AND 1 PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE WAS NOT CONFIRMED UPON INSPECTION OF THE SAMPLES. NO DAMAGES, ABNORMALITIES OR OTHER ISSUES WERE OBSERVED ON THE SAMPLE. BD CANNOT DETERMINE A MANUFACTURING ROOT CAUSE SINCE THE FAILURE WAS NOT CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED 3 BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN HAD NEEDLES THAT COULD NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WITH X 3 OF THESE WE WERE UNABLE TO REMOVE THE NEEDLE AS THE TUBING BUNCHED UP."

    Description of Event or Problem · 0

    IT WAS REPORTED 3 BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN HAD NEEDLES THAT COULD NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WITH X 3 OF THESE WE WERE UNABLE TO REMOVE THE NEEDLE AS THE TUBING BUNCHED UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477699 BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383313 9049997 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown