BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 11388462 · Received February 26, 2021

    Report

    Report Number
    9610847-2021-00087
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 3, 2021
    Report Date
    March 15, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 0171902. 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. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THIS IS THE FIRST COMPLAINT FOR FOREIGN MATTER ON MATERIAL 383319 & BATCH 0171902. SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383319 BATCH NO.: 0171902 FOUND A LINT ON NEEDLE BEFORE INSERTION. NEEDLE DISCARDED BY DENISE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383319 BATCH NO.: 0171902 FOUND A LINT ON NEEDLE BEFORE INSERTION. NEEDLE DISCARDED BY DENISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282491 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0171902

    Patients

    Seq Age Sex Outcome Treatment
    1