BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD UNSPECIFIED IV PIGGYBACK SECONDARY SET

    MDR report key: 17925875 · Received October 12, 2023

    Report

    Report Number
    9616066-2023-02064
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    April 13, 2023
    Report Date
    September 21, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF COMPLAINT REFERENCE PR (B)(4) REPORTED VIA POST MARKET SURVEY. HOWEVER THE CUSTOMER SUGGESTED THAT LEAKAGE WAS DETECTED FROM A SECONDARY INFUSION SET DURING INFUSION. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. IN THIS INSTANCE A LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE OR ADDITIONAL INFORMATION ABOUT THE EXACT NATURE OF THE DEFECT IT IS NOT POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD UNSPECIFIED IV PIGGYBACK SECONDARY SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICIAN EXPERIENCED: Q3D - FOR EACH OF THE COMPLICATIONS / DEVICE FAILURES THAT WERE RELATED TO THE LAST BD /CAREFUSION SECONDARY SET (IV PIGGYBACK SET) YOU USED IN THIS PATIENT, PLEASE INDICATE WHETHER EACH OF THE FOLLOWING APPLIED? YES, I DID ENCOUNTER LEAKAGE WITH THE LAST BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) I USED IN THIS PATIENT (NOT RESULTING IN HARM). S7X - THINKING ABOUT THE LAST BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) THAT YOU PERSONALLY USED ON A SINGLE PATIENT, PLEASE INDICATE HOW THE DEVICE WAS USED? ATTACHED TO THE UPPER IV ACCESS PORT OF A PRIMARY ADMINISTRATION SET. S8 - THINKING ABOUT THE LAST BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) THAT YOU PERSONALLY USED, PLEASE INDICATE THE AGE GROUP OF THE PATIENT? LESS THAN 4 WEEKS OLD. Q2B - PLEASE IDENTIFY THE FLUID(S) THAT LEAKED WITH THE LAST BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) YOU USED IN THIS PATIENT? CHEMOTHERAPY. Q2C - THINKING ABOUT THE LAST BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) YOU USED IN THIS PATIENT, DID YOU ENCOUNTER ANY OTHER COMPLICATIONS / DEVICE FAILURES APART FROM LEAKAGE? NO, I DID NOT ENCOUNTER OTHER COMPLICATIONS / DEVICE FAILURES WITH THE LAST BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) I USED IN THIS PATIENT. Q3B - FOR EACH OF THE COMPLICATIONS / DEVICE FAILURES THAT YOU ENCOUNTERED WITH THE LAST BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) YOU USED IN THIS PATIENT, WHICH OF THE FOLLOWING BEST DESCRIBES THE RELATIONSHIP BETWEEN THE COMPLICATION / DEVICE FAILURE AND THE USE OF THE BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) ITSELF? DURING INTERMITTENT INFUSION OF MEDICATIONS PROBABLE. NO, I WOULD PREFER TO REMAIN ANONYMOUS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311742 BD UNSPECIFIED IV PIGGYBACK SECONDARY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown