BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULONG NANOLINE

    MDR report key: 7002740 · Received November 6, 2017

    Report

    Report Number
    9611612-2017-00010
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 24, 2017
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K053283
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    USER FACILITIES REPORT NUMBER: (B)(4). BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). DR. (B)(6) WAS PERFORMING A LEFT INFRACLAVICULAR CATHETER PLACEMENT. ACCORDING TO THE DOCTOR, THEY COULD NOT GET ANY STIMULATION. HE SAID HE USUALLY ONLY INSERTS THE CATHETER A FEW CENTIMETERS PAST THE TIP OF THE NEEDLE. WHEN THEY COULD NOT GET A STIMULATION, THE NEEDLE AND CATHETER WERE PULLED OUT TOGETHER. THIS IS WHEN HE SAID THE CATHETER SHEERED AND LEFT A PIECE IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 2ND KIT AND BROKEN PIECE WAS SURGICALLY REMOVED 7 DAYS LATER. HOSPITAL WOULD NOT RELEASE CATHETER BEING HELD IN PATHOLOGY BUT I WAS ABLE TO EXAMINE IT AND TAKE PICTURES. THE AMOUNT OF CATHETER LEFT IN THE PATIENT (CLOSE TO 7 CM) IS INCONSISTENT WITH THE DOCTOR'S DESCRIPTION OF THE PROCEDURE. WHEN DR. (B)(6) WAS UNABLE TO STIMULATE, RATHER THAN REMOVE THE CATHETER AND NEEDLE TOGETHER, THE TUOHY NEEDLE SHOULD HAVE BEEN REMOVED FIRST, LEAVING THE CATHETER IN PLACE. AT THAT TIME THE CATHETER COULD THEN BE REMOVED SAFELY. THERE IS NOTHING I OBSERVED ON THE CATHETER OR 50 MM TUOHY NEEDLE THAT INDICATED ANY FLAWS THAT COULD HAVE CONTRIBUTED TO THE SHEERING OF THE CATHETER. PER THE INFORMATION AT (B)(6) PATHOLOGY LAB: DATE OF PROCEDURE: (B)(6) 2017. DATE OF REMOVAL OF CATHETER PIECE: (B)(6) 2017 (B)(4). CATHETER PIECES REVIEWED AND PICTURES TAKEN ON (B)(6) 2017.

    Description of Event or Problem · 1

    (B)(4). INITIAL REPORTERS NARRATIVE: DR. (B)(6) WAS PERFORMING A LEFT INFRACLAVICULAR CATHETER PLACEMENT. ACCORDING TO THE DOCTOR, THEY COULD NOT GET ANY STIMULATION. HE SAID HE USUALLY ONLY INSERTS THE CATHETER A FEW CENTIMETERS PAST THE TIP OF THE NEEDLE. WHEN THEY COULD NOT GET A STIMULATION, THE NEEDLE AND CATHETER WERE PULLED OUT TOGETHER. THIS IS WHEN HE SAID THE CATHETER SHEERED AND LEFT A PIECE IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 2ND KIT AND BROKEN PIECE WAS SURGICALLY REMOVED 7 DAYS LATER. HOSPITAL WOULD NOT RELEASE CATHETER BEING HELD IN PATHOLOGY BUT I WAS ABLE TO EXAMINE IT AND TAKE PICTURES. THE AMOUNT OF CATHETER LEFT IN THE PATIENT (CLOSE TO 7CM) IS INCONSISTENT WITH THE DOCTOR'S DESCRIPTION OF THE PROCEDURE. WHEN DR. (B)(6) WAS UNABLE TO STIMULATE, RATHER THAN REMOVE THE CATHETER AND NEEDLE TOGETHER, THE TUOHY NEEDLE SHOULD HAVE BEEN REMOVED FIRST, LEAVING THE CATHETER IN PLACE. AT THAT TIME THE CATHETER COULD THEN BE REMOVED SAFELY. THERE IS NOTHING I OBSERVED ON THE CATHETER OR 50MM TUOHY NEEDLE THAT INDICATED ANY FLAWS THAT COULD HAVE CONTRIBUTED TO THE SHEERING OF THE CATHETER. PER THE INFORMATION AT (B)(6) PATHOLOGY LAB: DATE OF PROCEDURE: (B)(6) 2017. DATE OF REMOVAL OF CATHETER PIECE: (B)(6) 2017. (B)(6). CATHETER PIECES REVIEWED AND PICTURES TAKEN ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783851 STIMULONG NANOLINE CONTINUOUS PERIPHERAL NERVE BLOCK KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 531156-32C 1137

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other