BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M PICC/CVC SECUREMENT DEVICE + TEGADERM CHG CHLORHEXIDINE I. V. SECUREMENT DSG

    MDR report key: 6841893 · Received September 5, 2017

    Report

    Report Number
    2110898-2017-00108
    Event Type
    Injury
    Date Received
    September 5, 2017
    Report Date
    September 5, 2017
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    K080620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED BY REPORTER. SPECIFIC DATE OF EVENT WAS NOT AVAILABLE. CUSTOMER REPORTED THE ISSUE OCCURRED WITHIN THE LAST FOUR MONTHS (INITIATION OF PRODUCT USE). NO LOT NUMBER WAS AVAILABLE. WITHOUT A LOT NUMBER, EXPIRATION DATE AND MANUFACTURER DATE CANNOT BE DETERMINED. NO LOT NUMBER WAS PROVIDED AND NO SAMPLE HAS BEEN RECEIVED TO DATE. CUSTOMER REPORTED THIS PATIENT WORKS OUTSIDE IN 100 DEGREE TEMPERATURES AND THE DRESSING WAS EXPOSED TO SWEATING. THERE WERE THREE SIMILAR PATIENT REPORTS FROM THIS FACILITY. THREE REPORTS (2110898-2017-00104, 2110898-2017-00107 AND 2110898-2017-00108) WERE SENT TO THE FDA. A SKIN REACTION MAY BE RELATED TO A NUMBER OF FACTORS INCLUDING SITE PREPARATION, APPLICATION, AND SITE MAINTENANCE. THE PACKAGE INSERT PROVIDES THE FOLLOWING INFORMATION: PRECAUTIONS: THE SKIN SHOULD BE DRY AND FREE OF DETERGENT RESIDUE. ALLOW ALL PREPS AND PROTECTANTS TO DRY COMPLETELY BEFORE APPLYING THE DRESSING TO PREVENT SKIN IRRITATION AND TO ENSURE GOOD ADHESION. SITE PREPARATION..... PREPARE THE SITE ACCORDING TO INSTITUTION PROTOCOL. CLIPPING OF HAIR AT SITE MAY IMPROVE DRESSING ADHESION. SHAVING IS NOT RECOMMENDED. THE SKIN SHOULD BE CLEAN, DRY AND FREE OF DETERGENT RESIDUE. ALLOW ALL PREPS AND PROTECTANTS TO DRY COMPLETELY BEFORE APPLYING THE DRESSING TO PREVENT SKIN IRRITATION AND TO ENSURE GOOD ADHESION....... SITECARE: THE SITE SHOULD BE OBSERVED DAILY FOR SIGNS OF INFECTION OR OTHER COMPLICATIONS.... INSPECT THE DRESSING DAILY AND CHANGE THE DRESSING AS NECESSARY, IN ACCORDANCE WITH FACILITY PROTOCOL. DRESSING CHANGES SHOULD OCCUR AT LEAST EVERY 7 DAYS, PER CURRENT CDC RECOMMENDATIONS AND MAY BE NEEDED MORE FREQUENTLY WITH HIGHLY EXUDATIVE SITES OR IF INTEGRITY OF THE DRESSING IS COMPROMISED. THE TEGADERM(TM) CHG DRESSING SHOULD BE CHANGED AS NECESSARY: IF THE DRESSING BECOMES LOOSE, SOILED OR COMPROMISED IF THE SITE IS OBSCURED OR NO LONGER VISIBLE IF THERE IS VISIBLE DRAINAGE OUTSIDE THE GEL PAD IF THE DRESSING APPEARS TO BE SATURATED OR OVERLY SWOLLEN TO TEST IF THE DRESSING IS FULLY SATURATED, LIGHTLY PRESS DOWN ON A CORNER OF THE GEL PAD WITH YOUR FINGER. IF THE GEL PAD REMAINS DISPLACED ONCE YOUR FINGER IS REMOVED, THE DRESSING SHOULD BE CHANGED. NOTE: TEGADERM¿ CHG DRESSING IS NOT DESIGNED TO ABSORB LARGE QUANTITIES OF BLOOD OR FLUID. 3M VASCULAR ACCESS SPECIALIST FOLLOWED-UP WITH ACCOUNT TO PROVIDE ASSESSMENT AND PRODUCT EDUCATION ON 8/23/2017.

    Description of Event or Problem · 1

    A NURSE ALLEGED A (B)(6) MALE OUTPATIENT EXPERIENCED SEVERE MACERATION WHEN 1877-2100 PICC/CVC DEVICE + TEGADERM CHG DRESSING WAS APPLIED TO HIS PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) SITE. THE PICC CATHETER WAS REPORTEDLY REMOVED DUE TO SKIN CONDITION AND A NEW PICC WAS INSERTED IN HIS OTHER ARM. THE PATIENT COMPLAINED OF PAIN/ SKIN IRRITATION AND REFUSED TO CONTINUE WITH IV THERAPY. THE PATIENT'S IV TREATMENT WAS REPORTEDLY CUT SHORT AND HE WAS SWITCHED TO ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623363 3M PICC/CVC SECUREMENT DEVICE + TEGADERM CHG CHLORHEXIDINE I. V. SECUREMENT DSG PICC/CVC DEVICE + TEGADERM CHG DRESSING FRO 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention