BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 9955064 · Received April 13, 2020

    Report

    Report Number
    3012307300-2020-03050
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Date of Event
    March 15, 2020
    Report Date
    May 28, 2020
    Manufacturer
    SMITHS MEDICAL ASD,INC.
    Product Code
    FPA
    UDI-DI
    10610586023279
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CADD EXTENSION SET WAS RETURNED FOR ANALYSIS. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 24" AND NORMAL CONDITIONS OF ILLUMINATION. NO ANOMALIES WERE FOUND. THE SAMPLE RETURNED WAS TESTED USING THE HYDROSTATIC VESSEL IN ORDER TO DETECT ANY DISCREPANCIES THAT COULD AFFECT THE PRODUCT FUNCTIONALITY. LEAKAGE WAS DETECTED IN FILTER. A REVIEW OF THE MANUFACTURING PROCESS WAS CONDUCTED AND NO DISCREPANCIES WERE FOUND. A REVIEW OF THE PRODUCTION FLOOR WAS CONDUCTED, A SAMPLE OF 32 UNITS WERE TAKEN IN ORDER TO VERIFY THAT ALL JOINS ARE PROPERLY ADHERED; NO DISCREPANCIES WERE DETECTED. DEVICE HISTORY REVIEW: PART NUMBER =21-7106-24. LOT NUMBER =3891179. QTY RELEASED=(B)(4) UNITS. MFG DATE=AUGUST 2019. IDR, DMR, OR DA=NONE PER REVIEW OF THE DHR.

    Description of Event or Problem · 1

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL CADD EXTENSION SET. A PATIENT RECEIVING ( "BLINCYTO" PROVIDED BY (B)(4) INCOUNGERED LEAKING AROUND THE AIR VENT PART OF THE FILTER. THIS OCCURED 96 HOURS AFTER INFUSING STARTED. PATIENT HAS A PICC (A PERIPHERALLY INSERTED CENTRAL CATHETER). WHEN ASSESSING IF LEAKING WAS COMING FROM THERE BY THE DOCTOR, NO OCCLUSION WAS OBSERVED. THE PICC LINE HAD GOOD BLOOD RETURN AND WAS FLUSHING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415745 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD,INC. SET, EXTENSION, 60", TOTM, 0.2 3891179 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1