BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRST PICC

    MDR report key: 2524813 · Received March 28, 2012

    Report

    Report Number
    1625425-2012-00030
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    February 14, 2012
    Report Date
    March 21, 2012
    Manufacturer
    ARGON MEDICAL DEVICES, INC
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    REC'D A NOTIFICATION FROM THE HOSPITAL'S ONCOLOGY SECTOR ON (B)(6) 2012 REGARDING PICC PRODUCT. ACCORDING TO THE CUSTOMER "THE CHILD WAS RECEIVING CHEMOTHERAPY DAILY WHEN THE PICC INSERTED HAD RUPTURED AND A REMAINING PART STAYED IN THE PT'S BODY. IT WAS PERFORMED A CATHETERIZATION TO REMOVE THE REMAINING PART. THE PT COULD NOT RECEIVE THE ONCOLOGY TREATMENT FOR 2 DAYS. THE CATHETER (REMAINING PART) WAS REMOVED BUT THE HEMODYNAMIC'S DOCTOR DISCARDED IT. THE OTHER PART OF THE CATHETER WAS SENT FOR ANALYSIS. ON (B)(4) 2012 WE REC'D AN EMAIL FROM (B)(4) REQUESTING AN INVESTIGATION RESPONSE FOR THE SAME COMPLAINT DESCRIBED ABOVE BECAUSE THE CUSTOMER ALSO REPORTED THE COMPLAINT TO (B)(4). THE REPORT THAT (B)(4) REC'D FROM THE CUSTOMER IS DESCRIBED BELOW: "PICC CATHETER INSERTED IN THE PT SINCE (B)(6) 2011 FOR ONCOLOGY TREATMENT PERFORMED PROPERLY UNTIL (B)(6) 2012 WHEN IT RUPTURED AND THE REMAINING PART OF THE CATHETER MIGRATED TO THE PT'S PULMONARY ARTERY (CONFIRMED BY X-RAYS AND CT). THE PT REQUIRED HOSPITALIZATION FOR THE CATHETER REMOVAL BY CATHETERIZATION UNDER SEDATION IN ANOTHER HOSPITAL. THE CHEMOTHERAPY PROTOCOL WAS NOT FOLLOWED BECAUSE THE CATHETER INSERTED ON RIGHT SUPERIOR MEMBER RUPTURED. THE FRAGMENT OF THE CATHETER WAS LOCATED IN THE PULMONARY ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other