BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 9699621 · Received February 12, 2020

    Report

    Report Number
    9610847-2020-00047
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 23, 2020
    Report Date
    February 14, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9143637. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS AND ALL INSPECTIONS PERFORMED WERE FOUND TO BE WITHIN SPECIFICATION. TO FURTHER INVESTIGATE THE REPORTED CONCERN, TWO PHYSICAL SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, NO DAMAGES WERE OBSERVED. THE SAMPLES WERE FUNCTIONALLY TESTED AND THEY WERE FOUND TO PERFORM PER SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, A MANUFACTURING RELATED CAUSE FOR THE REPORTED CONCERNS CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE CONCERNS ABOUT THE SAFETY MECHANISM WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS). ALTHOUGH THE CUSTOMER DID SAY NOTHING HAPPENED THEY ARE FEARFUL THAT IT MIGHT HAVE A PROBLEM WITH SAFETY SHIELD FAILURE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE CONCERNS ABOUT THE SAFETY MECHANISM WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS). ALTHOUGH THE CUSTOMER DID SAY NOTHING HAPPENED THEY ARE FEARFUL THAT IT MIGHT HAVE A PROBLEM WITH SAFETY SHIELD FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166924 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9143637

    Patients

    Seq Age Sex Outcome Treatment
    1 Other