BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ INFUSION SET

    MDR report key: 13214461 · Received January 10, 2022

    Report

    Report Number
    2243072-2021-03083
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    November 19, 2021
    Report Date
    January 19, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF BIRTH: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THERE IS AN OVER INFUSION OR BACK CHECK VALVE FAILURE. THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE MODEL AND LOT NUMBERS ARE UNKNOWN. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ INFUSION SET INFUSED VANCOMYCIN TOO QUICKLY AFTER HANGING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OVER INFUSION OR BACK CHECK VALVE FAILURE- NURSE HUNG VANCOMYCIN @ 2000 AND PT WENT DOWN FOR CT OF CHEST AND WHEN HE GOT BACK AT 2100 THE MEDICATION BAG WAS COMPLETELY EMPTY. THE PUMP STILL SAID THAT THERE WAS SUPPOSED TO BE 139 ML LEFT TO INFUSE AND THE RATE WAS SET TO THE CORRECT RATE OF 140ML/ HR."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ INFUSION SET INFUSED VANCOMYCIN TOO QUICKLY AFTER HANGING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OVER INFUSION OR BACK CHECK VALVE FAILURE NURSE HUNG VANCOMYCIN @ 2000 AND PT WENT DOWN FOR CT OF CHEST AND WHEN HE GOT BACK AT 2100 THE MEDICATION BAG WAS COMPLETELY EMPTY. THE PUMP STILL SAID THAT THERE WAS SUPPOSED TO BE 139 ML LEFT TO INFUSE AND THE RATE WAS SET TO THE CORRECT RATE OF 140ML/ HR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286258 UNSPECIFIED BD¿ INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male