BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACRANIAL PRESSURE / TEMPERATURE MONITORING K

    MDR report key: 5095710 · Received September 22, 2015

    Report

    Report Number
    2023988-2015-00036
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    September 1, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(6) 2015: THE CUSTOMER COULD NOT REMEMBER THE PRODUCT AND PATIENT DETAILS. THE PATIENT WAS BEING MOVED UP IN BED AND THE BOLT WAS NOT ALTERED BUT THE TUBING BECAME CRIMPED OR STRESSED IN THE LINEN AND CAUSED THE BLUE AND BLACK PORTIONS TO PULL AWAY FROM EACH OTHER. THE WEIGHT OF THE BLACK PLUG THAT IS CONNECTED TO THE DEVICE MADE THE FIBER BEND ONCE IT WAS EXPOSED. LINKED TO MFG REPORT NUMBER: 2023988-2015-00035.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12/07/2015. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: BATCH HISTORY RECORDS MODEL 110-4BT FROM THE LAST 12 MONTHS SHOW THEY MET REQUIREMENTS BEFORE RELEASED TO FG FOR THE LOTS INFORMATION. COMPLAINT HISTORY, MODEL 110-4BT AND 110-4HMT, FROM OCT-2014 THROUGH SEP-2015 REVIEWED; THERE WERE (B)(4) OTHER COMPLAINTS THAT ISSUED WITH COMPLAINT CODE (B)(4), AND ONE OF THEM WAS CONFIRMED. (B)(4). CONCLUSION: PRODUCT WAS NOT RETURNED, AS IT WAS ACCIDENTLY DISCARDED BY FACILITY. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES OBSERVED DURING THE MANUFACTURING, PACKAGING OR INSPECTION OF DEVICES WHILE IN PROCESS. ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT DOES NOT ALLOW FOR CONFIRMATION NOR DENIAL OF REASONABLY FORESEEABLE MISUSE OF THE CATHETER. ADDITIONALLY, BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, NO ROOT CAUSE ESTABLISHED FOR THE FAILURE MODE DESCRIBED IN THE CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS. THE CONNECTOR ON THE THERMISTOR OF THE 1104BT CAUSES THE INTRACRANIAL (ICP) CATHETER TO BEND AT A RIGHT ANGLE WHICH INADVERTENTLY CAUSES THE FIBEROPTIC CATHETER TO BREAK. THE CATHETER WAS IN THE PATIENT AT THE TIME WHEN THE INCIDENT OCCURRED. THE CATHETER ENDED UP BEING REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624302 INTRACRANIAL PRESSURE / TEMPERATURE MONITORING K N/A GWM INTEGRA NEUROSCIENCES CA/USA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention