BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAMINO CATHETER, UNKNOWN

    MDR report key: 5764772 · Received July 1, 2016

    Report

    Report Number
    2023988-2016-00024
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    June 17, 2016
    Report Date
    June 17, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 08/01/2016. THE DEVICE WAS NOT RETURNED FOR EVALUATION SINCE THE CUSTOMER HAD DISCARDED THE DEVICE. SALES ORDER HISTORY: ONE LOT WAS 111E00199058. CAMINO CATHETER, MODEL 110-4B. LOT WAS MANUFACTURE ON 31-JAN-2016 AND WILL BE EXPIRED ON 02-FEB-2019. LOT 111E00199058 MET ALL REQUIREMENTS BEFORE RELEASED TO FINISHED GOODS. COMPLAINT HISTORY, MODEL 110-4XXX, FROM JUN-2015 THROUGH MAY-2016 REVIEWED; THERE WERE FOUR OTHER COMPLAINTS THAT ISSUED WITH COMPLAINT CODE PERF032, AND ONE OF THEM WAS CONFIRMED. FAILURE RATE PERCENTAGE (B)(4). THE CUSTOMER¿S COMPLAINT COULD NOT BE CONFIRMED. THE CUSTOMER DID NOT RETURN THE CATHETER FOR EVALUATION. NO ROOT CAUSE COULD BE ESTABLISHED FOR THE FAILURE MODE DESCRIBED IN THE CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    THE CAMINO CATHETER THAT HAD BEEN IN A PATIENT HAD CAME OUT OF PLACE ( IT WAS NOT KNOWN HOW IT HAPPENED). THERE WAS NO PATIENT INJURY REPORTED. HOWEVER, THEY REPLACED THE CATHETER WITH A NEW ONE BUT THE MONITOR STILL WOULD NOT GIVE THEM ANY READINGS, INSTEAD THEY WERE JUST BEING TOLD THE CATHETER WAS NOT CONNECTED PROPERLY. THE STAFF THEN TRIED TO USE A DIFFERENT MONITOR AND THIS TIME IT WOULD NOT GO PAST THE START SCREEN. THE MONITORS WERE AT THE HOSPITAL ON A LONG TERM LOAN BASIS. THE EVENT DID NOT LEAD TO AN INCREASE OF SURGERY. ADDITIONAL INFORMATION WAS REQUESTED AND ON 27JUN2016, THE FOLLOWING WAS PROVIDED: THE CUSTOMER DOES NOT HAVE THE CATHETER TO RETURN. THEY USED A COMPETITOR PRODUCT (RAUMEDIC) TO CONTINUE MONITORING THE PATIENT. LINKED TO MFG. REPORT NUMBER: 3006697299-2016-00150 (1ST CAMINO MONITOR USED) AND 3006697299-2016-00152 (2ND MONITOR USED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420405 CAMINO CATHETER, UNKNOWN N/A GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention