BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CONTINUOUS NERVE BLOCK KIT

    MDR report key: 4891641 · Received July 6, 2015

    Report

    Report Number
    1036844-2015-00278
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 19, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    OGJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE CATHETER FRAGMENT FOR INVESTIGATION. A VISUAL EXAM WAS PERFORMED AND THE CATHETER PIECE APPEARS TO BE THE BULLETED TIP FROM THE DISTAL END OF A STIMUCATH. NO EXTRUSION WAS RECEIVED. THE COILS WERE SEVERELY STRETCHED AND THE SAFETY RIBBON COULD BE SEEN IN BETWEEN THE COILS. THE SAFETY RIBBON APPEARS TO HAVE BEEN CUT AT THE POINT OF SEPARATION AS THERE WERE SIGNS OF NECKING IN THE METAL THAT IS TYPICAL OF METAL THAT HAS BEEN CUT. THE REPORTED COMPLAINT OF A DIFFICULT REMOVAL RESULTING IN CATHETER SEPARATION WAS CONFIRMED BASED ON THE RETURNED SAMPLE. THE CUSTOMER RETURNED A CATHETER FRAGMENT ONLY WHICH CONFIRMED THAT THE CATHETER HAD BEEN CUT. A DHR REVIEW WAS PERFORMED ON THE CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE CUSTOMER REPORTED THAT THE CATHETER WAS REMOVED BY A FRIEND OF THE PATIENT AND ALSO THAT THE CATHETER WAS CUT. BOTH OF THESE DETAILS INDICATE THAT THE CATHETER WAS USED AGAINST THE WARNINGS PROVIDED IN THE IFU. THEREFORE, IT WAS DETERMINED THAT USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON A LOT NUMBER BASED ON CUSTOMER SALES HISTORY. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DHR REVIEW WAS PERFORMED ON THE CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE CUSTOMER REPORTED THAT THE CATHETER WAS REMOVED BY A FRIEND OF THE PATIENT AND ALSO THAT THE CATHETER WAS CUT. BOTH OF THESE DETAILS INDICATE THAT THE CATHETER WAS USED AGAINST THE WARNINGS PROVIDED IN THE IFU. THEREFORE, IT WAS DETERMINED THAT USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD AN INTERSCALENE CATHETER PLACED IN THE NECK BY AN ANESTHESIOLOGIST PRIOR TO SHOULDER SURGERY ON (B)(6) /2015. THE PATIENT WAS INSTRUCTED ON HOW TO REMOVE THE CATHETER WHICH WAS TO BE DONE ON (B)(6) 2015. THE PATIENT'S FRIEND ATTEMPTED TO REMOVE THE CATHETER AND MET WITH RESISTANCE AND SO CUT THE CATHETER. THE PATIENT EXPERIENCED DISCOMFORT. THE PATIENT IS TO BE SEEN BY AN ENT FOR INTERVENTION IN REMOVAL OF THE REMAINING CATHETER.

    Description of Event or Problem · 1

    THE PATIENT HAD AN INTERSCALENE CATHETER PLACED IN THE NECK BY AN ANESTHESIOLOGIST PRIOR TO SHOULDER SURGERY ON (B)(6) 2015. THE PATIENT WAS INSTRUCTED ON HOW TO REMOVE THE CATHETER WHICH WAS TO BE DONE ON (B)(6) 2015. THE PATIENT'S FRIEND ATTEMPTED TO REMOVE THE CATHETER AND MET WITH RESISTANCE AND SO CUT THE CATHETER. THE PATIENT EXPERIENCED DISCOMFORT. THE PATIENT IS TO BE SEEN BY AN ENT FOR INTERVENTION IN REMOVAL OF THE REMAINING CATHETER.

    Description of Event or Problem · 1

    THE PATIENT HAD AN INTERSCALENE CATHETER PLACED IN THE NECK BY AN ANESTHESIOLOGIST PRIOR TO SHOULDER SURGERY ON (B)(6) 2015. THE PATIENT WAS INSTRUCTED ON HOW TO REMOVE THE CATHETER WHICH WAS TO BE DONE ON (B)(6) 2015. THE PATIENT'S FRIEND ATTEMPTED TO REMOVE THE CATHETER AND MET WITH RESISTANCE AND SO CUT THE CATHETER. THE PATIENT EXPERIENCED DISCOMFORT. THE PATIENT IS TO BE SEEN BY AN ENT FOR INTERVENTION IN REMOVAL OF THE REMAINING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436466 ARROW CONTINUOUS NERVE BLOCK KIT NERVE BLOCK KIT OGJ ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention