BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 9633799 · Received January 27, 2020

    Report

    Report Number
    3012307300-2020-00727
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    December 3, 2019
    Report Date
    September 3, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586020186
    PMA / PMN Number
    K933390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CADD ADMINISTRATION SETS - NON FLOW STOP WAS RETURNED FOR ANALYSIS DUE TO LEAKAGE. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12? TO 16? UNDER NORMAL CONDITIONS OF ILLUMINATION. THE SAMPLE WAS RECEIVED BROKE FROM FILTER, THE COILED TUBE CAME WITH A FILTER PORT INSIDE IT. THE MANUFACTURING PROCESS WAS REVIEWED. PRODUCTION PERSONNEL PERFORM A PULL TEST ON 4 UNITS, AT SHIFT START UP, THE BEGINNING OF EVERY JOB, THE END OF EVERY JOB; A NEW LOT OF MATERIALS/COMPONENTS OR EQUIPMENT ADJUSTED. DURING THE MANUFACTURING PROCESS, PRODUCTION PERSONNEL DO A VISUAL INSPECTION BEFORE A PROCESS (ASSEMBLE, BOND, ETC.) TO ENSURE THAT THE MATERIAL IS IN PERFECT SHAPE; ALSO RIGHT AFTER A WORK STATION, PERSONNEL REDO AN INSPECTION TO THE FILTER IN ORDER TO FIND ANY DISCREPANCIES, FOLLOWING THE FOLLOWING CRITERIA. HOLES IN FILTER MEMBRANE. -INCOMPLETE OR POOR FILTER ASSEMBLY. QUALITY PERSONNEL TAKE A SAMPLE OF 15 UNITS EVERY 2 HOURS, PRIOR TO PLACING PRODUCT IN BAG IN ORDER TO INSPECT THE FILTER FOR PROPER HOUSING WELDS OR OTHER WORKMANSHIP DEFECTS. PARTS ARE FREE OF DAMAGE (SCUFFS, PINCH MARKS, ETC.), CRACKS, CRAZING, CUTS, OR OTHER WORKMANSHIP DEFECTS THAT CAN AFFECT ASSEMBLY FUNCTION OR APPEARANCE. THE MOST PROBABLE ROOT CAUSE IS THAT THE FILTER WAS DAMAGED AFTER THE PRODUCT LEFT THE FACILITY. DEVICE HISTORY REVIEW: PART NUMBER: 21-7036-01 LOT NUMBER: 3840952 MANUFACTURING DATE: JULY, 2019 QUANTITY RELEASED: (B)(4) ANY RELEVANT DMRS, IDRS, DAS: THERE WERE NO RELEVANT IDR'S, DMR'S OR DA'S FOR THIS LOT. ANY RELEVANT REWORK: NONE PER REVIEW OF THE DHR'S. WAS SCRAP/REJECTS ABOVE TYPICAL? NONE PER REVIEW OF THE DHR'S. COMPONENT LOT NUMBER AND QUANTITY ISSUED: THERE IS NO COMPONENT ASSOCIATED WITH THIS COMPLAINT. COMPONENT HISTORY: THERE IS NO COMPONENT ASSOCIATED WITH THIS COMPLAINT. SUMMARY OF DHR REVIEW: THERE WERE NO RELEVANT FINDINGS DETECTED IN THE DHR'S.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET LEAKED A SIGNIFICANT AMOUNT OF BLOOD AND THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS BROKEN IN TWO, CRACKING THE AIR FILTER. THE REPORTER INDICATED THAT PER THE CLIENT, THE CAUSE OF THE DAMAGE IN THIS EVENT WAS UNKNOWN. NO FURTHER ADVERSE EFFECTS WERE REPORTED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95763 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7036-01 3840952 10610586020186

    Patients

    Seq Age Sex Outcome Treatment
    1