BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16 IN NON-DEHP STND BORE EXTENSION SET

    MDR report key: 10570911 · Received September 22, 2020

    Report

    Report Number
    9616066-2020-02734
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    July 28, 2020
    Report Date
    September 2, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FPA
    UDI-DI
    10885403237652
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO NO PHOTO OR SAMPLE BEING RECEIVED, THE CUSTOMER'S COMPLAINT OF LEAKAGE COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOR MODEL MX9166 LOT NUMBER 19017181 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(6) IN 1 LOT NUMBER WAS BUILT ON 30JAN2019. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 16 IN NON-DEHP STND BORE EXTENSION SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MX9166 BATCH NO: 19017181 IT WAS REPORTED THAT PATIENT NOTICED LEAKING FROM FILTER AND STATED THIS HAPPENED 3 TIMES. EVENT DESCRIPTION: DURING INFUSION OF DARATUMUMAB STUDY DRUG PT NOTICED LEAKING COMING FROM FILTER; INFUSION STOPPED; IDS PHARMACY CALLED AND FILTER REPLACED - SITE CLEANED WITH SOAP AND WATER; INFUSION RESUMED WITH NEW FILTER; PT STATED THIS IS 3RD INCIDENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 16 IN NON-DEHP STND BORE EXTENSION SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MX9166, BATCH NO: 1901718. IT WAS REPORTED THAT PATIENT NOTICED LEAKING FROM FILTER AND STATED THIS HAPPENED 3 TIMES. EVENT DESCRIPTION: DURING INFUSION OF DARATUMUMAB STUDY DRUG PT NOTICED LEAKING COMING FROM FILTER; INFUSION STOPPED; IDS PHARMACY CALLED AND FILTER REPLACED - SITE CLEANED WITH SOAP AND WATER; INFUSION RESUMED WITH NEW FILTER; PT STATED THIS IS 3RD INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031950 16 IN NON-DEHP STND BORE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION SD MX9166 19017181 10885403237652

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200728| 20200728