BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRST PICC

    MDR report key: 2524805 · Received March 28, 2012

    Report

    Report Number
    1625425-2012-00032
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    February 21, 2012
    Report Date
    March 23, 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

    THIS FAILURE COULD NOT BE VERIFIED DUE TO NO PRODUCT BEING RETURNED FOR EVAL. A ROOT CAUSE IS UNABLE TO BE DETERMINED; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. IF PRODUCT IS RETURNED IN THE FUTURE, THE ISSUE WILL BE RE-EVALUATED AT THAT TIME.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED OF A CATHETER BREAK. THE CATHETER BROKE AT THE INSERTION POINT AND ''OCCURRED'' MIGRATION FOR THE PT'S BLOODSTREAM AND WAS NECESSARY A CATHETERIZATION TO THE REMOVAL OF THE REMAINING PART." CHILD IS IN GOOD HEALTH AND WAS DISCHARGED FROM HOSPITAL TODAY. ADD'L INFO: DATE OF OCCURRENCE: (B)(6) 2012. DESCRIPTION OF OCCURRENCE: "THE NEW BORN AGITATED, WITH ABSTINENCE SYNDROME RECEIVING PARENTERAL NUTRITION DUE THE DIFFICULTY TO PROGRESS THE DIET AND TACHYPNEA NOT RESOLVED. ON (B)(4) 2012 AT 6 AM, ''IT WAS INFUSED RANITIDINE DILUTED IN SALINE SOLUTION AND AFTER THE CATHETER WAS SALINIZED WITH SALINE SOLUTION (WITH 10CC SYRINGE).'' NO SIGNS OF PERIPHERAL CATHETER OBSTRUCTION. AT 6:40 AM, IT WAS OBSERVED RUPTURE OF THE INITIAL PORTION OF THE CATHETER, BEFORE THE MARKING. THE PT WAS AGITATED AT THIS MOMENT. THE DRESSING WAS REMOVED IMMEDIATELY AND WAS ADHERED AT THE PT'S SKIN. THE CATHETER POINT WAS NOT OBSERVED. IT WAS PERFORMED A X-RAY AND OBSERVED THE CATHETER IN THE FEMORAL REGION TO VENTRICLE. PT WAS REMOVED TO EVAL FROM THORACIC SURGERY TEAM AND A CATHETERIZATION WAS PERFORMED TO REMOVAL. THE CATHETER WAS LOCATED AT THE VENTRICLE TO PULMONARY VEIN. ''IT WAS REMOVED THE CATHETER WITH 27CM OF EXTENSION.' IT WAS PERFORMED A NEW X-RAY AND NO ANOTHER PART WAS OBSERVED.'' ATTENTION FOR THE INCORRECT MEASUREMENT OF THE CATHETER. THE PT REMAINED IN THE ICU. CATHETER USED TO PARENTERAL NUTRITION AND RANITIDINE INTRAVENOUS INFUSION. PROCEDURE/TECHNIQUE USED: PICC INSERTED IN (B)(6) 2012 IN SAPHENOUS MAGNA VEIN (NEAR THE KNEE), PERFORMED ONLY ONE ATTEMPT WITH SUCCESS, NO DIFFICULTY TO PROGRESS OF THE CATHETER AND AFTER X-RAY CONFIRMED LOCAL POSITION OF CATHETER AT THE MIDDLE THIRD OF INFERIOR VENA CAVA. IT AS USED ANATOMICAL FORCEPS DURING INSERTION. USED A TEGADERM BASIC DRESSING TO COVER THE INSERTION LOCAL AND COVER WITH MICROPORE, AT THE OVAL DISK. CATHETER WAS FIXED IN "S" TO KEEP THE SECURITY. IN ACCORDANCE WITH CUSTOMER INTERNAL HOSPITAL REPORT WAS INSERTED 22CM OF CATHETER. THERE WAS NO DIFFICULTY DURING HANDLE/MANIPULATION OF THE PRODUCT. PT HAD 10 ADD'L DAYS OF HOSPITALIZATION BECAUSE OF THE INCIDENT. HOSPITAL FORM FILED: DATE OF BIRTH: (B)(6) 2012. GESTATIONAL AGE: (B)(6), MALE, BIRTH WEIGHT: (B)(6). DIAGNOSIS: DIFFICULT DIET PROGRESSION AND TACHYPNEA NOT RESOLVED. CATHETER INSERTION DATE: (B)(6) 2012 - WEIGHT (B)(6). INSERTED 22CM OF THE CATHETER. USED ALCOHOLIC CHLORHEXIDINE TO ASEPSIS. PROCEDURE TIME: 10'. NO SAMPLE AVAILABLE, BECAUSE AFTER THE CATHETERIZATION PROCEDURE, THE REMAINING PART WAS SENT TO MICROBIOLOGY AND THEY DISCARDED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES, INC. NA 0027392

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Other| R