BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN OPSITE

    MDR report key: 10231050 · Received July 5, 2020

    Report

    Report Number
    8043484-2020-01517
    Event Type
    Injury
    Date Received
    July 5, 2020
    Date of Event
    January 1, 1901
    Report Date
    February 10, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE USED IN TREATMENT WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED, THEREFORE, A RELATIONSHIP WAS NOT ESTABLISHED BETWEEN THE DEVICE AND THE REPORTED EVENT. ROOT CAUSE WAS NOT CONFIRMED. THERE IS NO EVIDENCE TO SUGGEST A DIRECT LINK BETWEEN PRODUCT AND REPORTED ALLEGATION. REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED, HOWEVER, AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT DID NOT MEET SPECIFICATIONS AT THE TIME OF MANUFACTURE. COMPLAINT HISTORY REVIEW FOR THREE PREVIOUS YEARS INDICATED SIMILAR ALLEGATIONS. INSTRUCTIONS FOR USE (IFU) CONTAIN RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. RISK MANAGEMENT FILES CONTAIN THE REPORTED ALLEGATION. NO UPDATE REQUIRED. POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MIGHT BE: PATIENT SENSITIVITY, ALLERGIC REACTION, APPLICATION OR DRESSING DIFFICULTIES. CLINICAL/MEDICAL INVESTIGATION WAS PERFORMED AND DETERMINED NO FURTHER ACTIONS REQUIRED. SMITH AND NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THE REPORTED ALLEGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIM OF THIS PROSPECTIVE AND RANDOMISED STUDY WAS TO DETERMINE WHETHER THE TUNNELLING OF AN EPIDURAL CATHETER INFLUENCES ITS MIGRATION. PATIENTS WERE RANDOMLY ALLOCATED TO RECEIVE ONE OF TWO METHODS OF SKIN FIXATION ACCORDING TO A PREVIOUSLY PREPARED PROTOCOL. THE METHOD OF EPIDURAL CATHETER INSERTION WAS STANDARDISED, AND AFTER ESTABLISHING INTRAVENOUS ACCESS, THE PATIENT WAS PLACED IN THE LEFT LATERAL POSITION. UNDER ASEPTIC CONDITIONS A 16-GAUGE TUOHY NEEDLE (PORTEX EPIDURAL SYSTEM 1 MINIPACK) WAS INSERTED VIA A MIDLINE APPROACH. THE EPIDURAL SPACE WAS LOCATED USING THE LOSS OF RESISTANCE TO AIR TECHNIQUE, AND WITH THE NEEDLE ORIFICE DIRECTED CEPHALAD THE CATHETER WAS INSERTED 4 CM INTO THE EPIDURAL SPACE. THE CATHETER HAD THREE SIDE HOLES AT 0.5, 1.0 AND 1.5 CM FROM THE DISTAL END AND HAD MARKS AT EVERY 1 CM FROM 5 TO 15 CM AND AT 20 CM FROM THE TIP. THE SKIN AND CATHETER NEAR THE SKIN EXIT SITE WERE SPRAYED WITH NOBECUTANE TRANSPARENT ADHESIVE SPRAY (ASTRA PHARMACEUTICALS PTY LTD) AND COVERED WITH A TRANSPARENT 10 CM BY 12 CM OPSITE ADHESIVE PLASTIC DRESSING (SMITH & NEPHEW MEDICAL LTD). ONE CATHETER WAS REMOVED BECAUSE OF INFECTION AT THE SKIN SITE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695166 UNKN OPSITE TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention