BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ VP INFUSION SET

    MDR report key: 16934713 · Received May 15, 2023

    Report

    Report Number
    9614033-2023-00033
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 24, 2023
    Report Date
    June 6, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY NO SAMPLES WERE RECEIVED FOR INVESTIGATION IN WHICH THE CUSTOMER HAS INDICATED THAT THEY OBSERVED LEAKAGE: "FROM THE MALE HUB," OF A 70693E PRODUCT FROM LOT 1024372. ADDITIONAL CORRESPONDENCE WITH THE CUSTOMER INDICATED THAT THE LEAKAGE WAS OBSERVED APPROXIMATELY THIRTY MINUTES INTO AN INFUSION OF 0.9% SALINE AND THAT NO DAMAGE OR DEFORMITY WAS NOTED TO THE COMPONENT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1024372 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ VP INFUSION SET LEAKED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SAME GIVING SET AS PER PREVIOUS COMPLAINT, HAS LEAKED FROM THE MALE HUB, CAUSING BACK FLOW OF BLOOD DIRECTLY FROM THE CVL."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ VP INFUSION SET LEAKED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SAME GIVING SET AS PER PREVIOUS COMPLAINT, HAS LEAKED FROM THE MALE HUB, CAUSING BACK FLOW OF BLOOD DIRECTLY FROM THE CVL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351003 BD ALARIS¿ VP INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON DE MEXICO 1024372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown