BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 10954493 · Received December 5, 2020

    Report

    Report Number
    9610847-2020-00396
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Date of Event
    August 28, 2020
    Report Date
    December 15, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 9143630. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM NEEDLE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "WHEN THE NURSE FOUND THAT THE END OF THE PATIENT'S SAFE INDWELLING NEEDLE WAS BROKEN (THE PATIENT HAS NO SPECIAL BEHAVIOR), SHE IMMEDIATELY REPLACED A NEW INDWELLING NEEDLE AND NOTIFY THE EQUIPMENT DEPARTMENT".

    Additional Manufacturer Narrative · 1

    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 NEEDLE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE NURSE FOUND THAT THE END OF THE PATIENT'S SAFE INDWELLING NEEDLE WAS BROKEN (THE PATIENT HAS NO SPECIAL BEHAVIOR), SHE IMMEDIATELY REPLACED A NEW INDWELLING NEEDLE AND NOTIFY THE EQUIPMENT DEPARTMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418737 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383313 9143630 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1