BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC® PORT-A-CATH®

    MDR report key: 7006054 · Received November 7, 2017

    Report

    Report Number
    3012307300-2017-02328
    Event Type
    Injury
    Date Received
    November 7, 2017
    Report Date
    January 16, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION NOTES THREE PART NUMBERS (21-4482-24 / 21-4070-24 / 21-4082-24) BUT IS UNCERTAIN AS TO WHICH PART NUMBER GOES WITH WHICH PRODUCT. REPORT SOURCE: (B)(6).

    Additional Manufacturer Narrative · 1

    ONE PORT WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION OF THE SAMPLE WAS PERFORMED AND REVEALED DAMAGE TO THE CATHETER IN THE FORM OF A CUT THAT PASSED BOTH WAYS. THE SAMPLE WAS ALSO TESTED WITH WATER WHICH CONFIRMED THE PRESENCE OF A LEAK. A REVIEW OF THE MANUFACTURING PROCESS WAS CONDUCTED AND WAS CONSIDERED ADEQUATE AND CORRECT. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVING CHEMOTHERAPY VIA A SMITHS MEDICAL DELTEC® PORT-A-CATH® WAS FOUND TO BE LEAKING INTO THE SUBCUTANEOUS TISSUE. HOLES WERE NOTED IN THE CATHETER ATTACHED TO THE PORT. SUBSEQUENTLY, THE PORT WAS EXPLANTED TO PREVENT "CELL POISON." THE PATIENT RECOVERED WITH NO FURTHER ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786046 DELTEC® PORT-A-CATH® PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention