BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH PICC S/L 28GA (1.2F) X25CM BASIC W/SN

    MDR report key: 3788313 · Received April 28, 2014

    Report

    Report Number
    1625425-2014-00014
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN THE COMPLAINT, THE CUSTOMER BELIEVED MEDICAL INTERVENTION WAS REQUIRED DUE TO MISPLACEMENT OF CATHETER, AND NOT DUE TO AN ISSUE WITH CATHETER ITSELF. IT IS UNKNOWN IF THE ISSUE WAS OBSERVED IMMEDIATELY AFTER THE CATHETER WAS INSERTED OR AFTER THE CATHETER WAS IMPLANTED FOR A PERIOD OF TIME. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES WHICH WOULD CAUSE THE ISSUE. CATHETERS ARE 100 PERCENT INSPECTED AT VARIOUS STAGES OF THE MANUFACTURING PROCESS. A PRESSURE TEST IS PERFORMED ON ALL CATHETERS DURING MANUFACTURING TO ENSURE THE CATHETERS CAN WITHSTAND THE PRESSURES AND FORCES WHEN UTILIZED WITHIN THE INSTRUCTIONS FOR USE. A CONTROL PULL TEST IS ALSO PERFORMED PER THE SPECIFICATIONS. ACCORDING TO THE IFU, PICC CATHETERS SHALL HAVE THE DISTAL TIP DWELLING IN THE LOWER ONE THIRD OF THE SUPERIOR VENA CAVA TO THE JUNCTION OF THE SUPERIOR VENA AND THE RIGHT ATRIUM. THE IFU STATES THAT FOR PROPER USE, CLINICIANS MUST BE FAMILIAR WITH AND TRAINED IN THE PLACEMENT, MAINTENANCE, AND USE OF PICC CATHETERS. THE IFU HAS INSTRUCTIONS FOR VERIFICATION OF PROPER PLACEMENT OF THE CATHETER. THE IFU ALSO STATES THAT THE EXTERNAL PORTION OF THE CATHETER MUST BE ADEQUATELY SECURED. THE ISSUE REPORTED ON THIS COMPLAINT WAS PROBABLY DUE TO IMPROPER PLACEMENT OF THE CATHETER AS ASSERTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    PATIENT REQUIRED INTUBATION AND CHEST TUBE. LINE WAS REMOVED. CUSTOMER BELIEVES MEDICAL INTERVENTION WAS REQUIRED DUE TO MISPLACEMENT OF CATHETER, AND NOT AN ISSUE WITH CATHETER ITSELF. NOTE: CUSTOMER DOES NOT BELIEVE THERE IS AN ISSUE WITH THIS CATHETER, BUT KEPT IT FOR EVALUATION BECAUSE OF A COMPLICATION THAT HAPPENED WITH PATIENT (PLEURAL EFFUSION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253532 L-CATH PICC S/L 28GA (1.2F) X25CM BASIC W/SN PICC FOZ ARGON MEDICAL DEVICES INC. 11046122

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention