BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEHPFREE PRI GRAV SET 1 SS VLV

    MDR report key: 10253727 · Received July 9, 2020

    Report

    Report Number
    9616066-2020-02214
    Event Type
    Death
    Date Received
    July 9, 2020
    Date of Event
    April 25, 2020
    Report Date
    June 25, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    UDI-DI
    07613203020893
    PMA / PMN Number
    K820278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF AIR BEING PRESENT IN THE LINE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 41173E BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ROOT CAUSE ANALYSIS: DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. INVESTIGATION CONCLUSION: THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEHPFREE PRI GRAV SET 1 SS VLV HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 41173E, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT TWO EVENTS INVOLVING BD SMARTSITE GRAVITY SET OCCURRED. CUSTOMER RESPONSE 07-JUL-2020: (B)(4). (B)(6) 2020 @ 1720. (B)(6). GRAVITY SET IN USE IN ED SETTING WITH FLUIDS RUNNING AND ANOTHER MEDICATION GIVEN THROUGH PORT. PT WENT TO CT AND AN AIR EMBOLISM WAS NOTED. PT. CODED AND EXPIRED LATER. WE DON¿T KNOW FOR A FACT THAT THERE IS AN ISSUE BUT ARE CONCERNED WITH 2 VERY SIMILAR EVENTS IN A SHORT AMOUNT OF TIME. CUSTOMER RESPONSE 30-JUN-2020: 2 EVENTS, 1 PT EXPIRED, 1 PT WAS SAFELY DISCHARGED. WE DO NOT HAVE THE ORIGINAL PRODUCT TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714038 DEHPFREE PRI GRAV SET 1 SS VLV INTRAVASCULAR ADMINISTRATION SET FPA CFN MEXICO 215 SA DE CV 41173E UNKNOWN 07613203020893

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death 20200425