BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 8977296 · Received September 9, 2019

    Report

    Report Number
    1416980-2019-04917
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Report Date
    September 26, 2019
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PATIENT IDENTIFIERS AND DEMOGRAPHICS (REMOVE N/A, ADD NI), PATIENT/HEALTH/DEVICE CODES (REMOVE 2645, 1371, ADD 2199, 1171, 435). EVENT CORRECTIONS: REMOVE ¿TWO (2) UNKNOWN ACCESS SETS WOULD NOT CONNECT FROM THE TUBING TO THE INTRAVENOUS HUB. IT WAS FURTHER REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO PUNCTURE WHEN SPIKING AN UNSPECIFIED ANTIBIOTIC. THIS WAS IDENTIFIED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT¿. CHANGE EVENT TO: AN UNSPECIFIED QUANTITY OF ACCESS SETS WERE DIFFICULT TO CONNECT TO THE IV (INTRAVENOUS) HUB AND BECAME DISCONNECTED MULTIPLE TIMES. THIS WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO (2) UNKNOWN ACCESS SETS WOULD NOT CONNECT FROM THE TUBING TO THE INTRAVENOUS HUB. IT WAS FURTHER REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO PUNCTURE WHEN SPIKING AN UNSPECIFIED ANTIBIOTIC. THIS WAS IDENTIFIED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770445 NI SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1