BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M TEGADERM CHLORHEXIDINE GLUCONATE IV PORT DRESSING

    MDR report key: 8623240 · Received May 20, 2019

    Report

    Report Number
    2110898-2019-00078
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    April 5, 2019
    Report Date
    May 20, 2019
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    UDI-DI
    30707387770366
    PMA / PMN Number
    K123679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER WAS NOT PROVIDED. WITHOUT A LOT NUMBER, EXPIRATION DATE AND MANUFACTURER DATE COULD NOT BE DETERMINED. WITHOUT A LOT NUMBER, A BATCH RECORD REVIEW COULD NOT BE PERFORMED. END OF REPORT.

    Description of Event or Problem · 1

    A NURSE REPORTED AN ADULT INPATIENT WAS RECEIVING A BLOOD INFUSION THROUGH THEIR IMPLANTED PORT CATHETER SITE. A 1665 TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING WAS USED TO COVER AND SECURE THE PATIENT'S HUBER NEEDLE. THE HUBER NEEDLE REPORTEDLY BECAME DISLODGED AND THE PATIENT EXPERIENCED AN INFILTRATION OF THE BLOOD INFUSION UNDER THEIR SKIN AT THE PORT SITE. A PERIPHERAL IV SITE WAS USED FOR IV ACCESS WHILE THE IMPLANTED PORT SITE HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417488 3M TEGADERM CHLORHEXIDINE GLUCONATE IV PORT DRESSING TEGADERM¿ CHG IV PORT DRESSING FRO 3M HEALTH CARE N/A UNK 30707387770366

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HUBER NEEDLE, UNSPECIFIED TYPE