BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT

    MDR report key: 5084720 · Received September 17, 2015

    Report

    Report Number
    1036844-2015-00414
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    September 3, 2015
    Report Date
    September 3, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    OGJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE 20GA STIMUCATH FOR INVESTIGATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CATHETER WAS USED AS BIOLOGICAL MATERIAL COULD BE SEEN ON BOTH THE DISTAL AND PROXIMAL EXPOSED COILS. THE COILS AT THE PROXIMAL END WERE DAMAGED. THE SAFETY RIBBON WAS PRESENT AND ATTACHED, HOWEVER, THE MOST DISTAL TIP OF THE COILS WERE UNRAVELED. NO OTHER DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS ALSO PERFORMED AND NO LEAKS WERE DETECTED. THE LOT NUMBER PROVIDED BY THE CUSTOMER IS NOT A VALID LOT NUMBER FOR THE REPORTED PRODUCT CODE. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED BASED ON A LOT NUMBER (23F15G1135) FROM SALES HISTORY OF THE CUSTOMER, AND THERE WERE NO RELEVANT FINDINGS. THE REPORTED COMPLAINT OF A CATHETER LEAK WAS NOT CONFIRMED BASED ON THE SAMPLE RECEIVED. THE RETURNED CATHETER PASSED A FUNCTIONAL LEAK TEST AND NO CRACKS WERE DETECTED ON THE CATHETER BODY. A DHR REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT WHEN THE DOCTOR WAS INJECTING THE DRUG INTO THE CATHETER, HE NOTICED THAT THE CATHETER HAD CRACKS ALL THE WAY DOWN. THE CATHETER LEAKED ALONG THE CATHETER. NO PATIENT INJURY OR CONSEQUENCE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT WHEN THE DOCTOR WAS INJECTING THE DRUG INTO THE CATHETER, HE NOTICED THAT THE CATHETER HAD CRACKS ALL THE WAY DOWN. THE CATHETER LEAKED ALONG THE CATHETER. NO PATIENT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615557 ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT ANESTHESIA CONDUCTION KIT OGJ ARROW INTERNATIONAL INC. 23F15E0139

    Patients

    Seq Age Sex Outcome Treatment
    1