BEUDAMED
    FDA Adverse Event Summary report: N

    STATSEAL DISC

    MDR report key: 6250839 · Received January 13, 2017

    Report

    Report Number
    1066421-2017-00001
    Date Received
    January 13, 2017
    Date of Event
    December 1, 2016
    Report Date
    January 31, 2017
    Manufacturer
    BIOLIFE, LLC
    Product Code
    FRO
    PMA / PMN Number
    K130324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 1

    EVALUATION OF BIOLIFE'S CHIEF MEDICAL ADVISOR DR. (B)(4). IN RESPONSE, THE INCIDENT WITH INVOLVING THE STATSEAL DISC AND THE NEONATE. IT APPEARS THAT A STERISTRIP WAS USED TO SECURE THE DISC. I SUSPECT THIS CREATED A SPECIFIC PRESSURE AREA THAT WITH THE TEXTURE OF THE DISC WOULD LEAD TO A SKIN BREAKDOWN. A STERISTRIP WOULD CREATE A UNIQUE POINT OF CONTACT THAT WOULD BE VERY DEFINED OVER A SMALL AREA. INCREASING THE RISK OF BREAKDOWN OR A TEAR BY CONTACT. APPLYING A MORE EVENLY DISTRIBUTED DRESSING WOULD MAKE MORE SENSE. (B)(6). SINGLE USE DEVICE.

    Description of Event or Problem · 1

    "A (B)(6) PATIENT IN WHICH THEY APPLIED THE STATSEAL DISC POST PICC INSERTION, AND THE PRODUCT SEEMED TO EAT AWAY AT THE SKIN. THEY FILLED OUT AN INCIDENT REPORT. THE WOUND CARE TEAM WAS CALLED IN. THE SITE HAD BRUISING. THEY DO NOT USE BIOPATCH. THEY USED CHLORHEXADINE GLUCONATE 1-2% ON PATIENTS >28 WEEKS. UNDER THIS AGE, THEY ONLY USE BETADINE AT THE INSERTION SITE".

    Description of Event or Problem · 1

    "A (B)(6) WEEK PATIENT IN WHICH THEY APPLIED THE STATSEAL DISC POST PICC INSERTION, AND THE PRODUCT SEEMED TO EAT AWAY AT THE SKIN. THEY FILLED OUT AN INCIDENT REPORT. THE WOUND CARE TEAM WAS CALLEDIN. THE SITE HAD BRUISING. THEY DO NOT USE BIOPATCH. THEY USED CHLORHEXADINE GLUCONATE 1-2% ON PATIENTS >28 WEEKS. UNDER THIS AGE , THEY ONLY USE BETADINE AT THE INSERTION SITE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34813 STATSEAL DISC STATSEAL DISC FRO BIOLIFE, LLC DT013

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Other