BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKER EDMS II

    MDR report key: 4822602 · Received June 5, 2015

    Report

    Report Number
    2021898-2015-00199
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    PMA / PMN Number
    K984053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER WAS 208764238; HOWEVER, THE RETURNED DEVICE WAS FROM LOT NUMBER 209029774. THE RETURNED DEVICE WAS PATENT. IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO THE DRAINAGE BAG LUER ADAPTOR BEING BROKEN OFF. THE DRAINAGE BAG WAS OBSERVED TO BE TAPED TO THE TUBING. THERE WAS PROTEINACEOUS DEBRIS OBSERVED IN THE DEVICE. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE STATE THAT ¿IN ORDER TO AVOID POSSIBLE CRACKING OF THE LUER CONNECTORS AFTER CLEANING WITH ALCOHOL, OR A DISINFECTANT CONTAINING ALCOHOL ALLOW TO AIR DRY COMPLETELY PRIOR TO CONNECTING THE SYSTEM.¿ IT IS ALSO CAUTIONED THAT ¿ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR¿. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ADDITIONAL PATIENT/DEVICE INFORMATION: ADDITIONAL INFORMATION REGARDING THE EVENT DATE AND PATIENT INITIALS, GENDER AND AGE WAS RECEIVED. IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE EVENT OCCURED AFTER 5-6 BAG CHANGES. (B)(4)

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER WAS 208764238; HOWEVER, THE RETURNED DEVICE WAS FROM LOT NUMBER 209029774. THE RETURNED DEVICE WAS PATENT. IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO THE DRAINAGE BAG LUER ADAPTOR BEING BROKEN OFF. THE DRAINAGE BAG WAS OBSERVED TO BE TAPED TO THE TUBING. THERE WAS PROTEINACEOUS DEBRIS OBSERVED IN THE DEVICE. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE STATE THAT ¿IN ORDER TO AVOID POSSIBLE CRACKING OF THE LUER CONNECTORS AFTER CLEANING WITH ALCOHOL, OR A DISINFECTANT CONTAINING ALCOHOL ALLOW TO AIR DRY COMPLETELY PRIOR TO CONNECTING THE SYSTEM.¿ IT IS ALSO CAUTIONED THAT ¿ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR¿. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PIECE THAT CONNECTS THE ITEM TO THE PATIENT BROKE IN HALF. ACCORDING TO THE REPORT, THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364220 BECKER EDMS II DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY 46128 209029774

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR