BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC PORT-A-CATH II POWER P.A.C

    MDR report key: 8701025 · Received June 14, 2019

    Report

    Report Number
    3012307300-2019-03604
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 1, 2019
    Report Date
    August 2, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DELTEC POWER PORT-A-CATH II PORT WAS RETURNED TO SMITH MEDICAL FOR INVESTIGATION. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 24" UNDER NORMAL CONDITIONS OF ILLUMINATION. THE TECHNICIAN OBSERVED THAT THE CATHETER WAS SEPARATED; A SMALL SECTION ATTACHED TO THE PORT AND A BIGGER SECTION IS LOOSE. MANUFACTURING PROCESS ALONG WITH THE IFU WERE REVIEWED WITH NO FINDINGS. BASED ON THE EVIDENCE THE COMPLAINT WAS CONFIRMED WITH THE MOST PROBABLE ROOT CAUSE IS THAT THE DAMAGE OCCURRED AFTER THE PRODUCT LEFT THE MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A "DEFECTIVE" SMITHS MEDICAL DELTEC PORT-A-CATH II POWER P.A.C PORT-A-CATH HAD TO BE REMOVED FROM THE PATIENT AFTER AN X-RAY. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493400 DELTEC PORT-A-CATH II POWER P.A.C PORT & CATHETER, IMPLANTED, SUBCUTANEOUS,INTRAVASCULAR, PRODUCT CODE: LJT LJT SMITHS MEDICAL ASD, INC. 3603228

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention