BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIMITORR VOLUME LIMITING EVD 20 ML

    MDR report key: 4814510 · Received June 1, 2015

    Report

    Report Number
    2648988-2015-00051
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Report Date
    May 5, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K072929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 06/10/2015. METHOD: EVAL OF ACTUAL DEVICE; REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINT HISTORY. RESULTS: THE CLEAR PVC TUBING MOST PROXIMAL TO THE CSF ACCESS PORT WAS DETACHED FROM THE STOPCOCK. UPON CLOSE EXAMINATION, TRACES OF ADHESIVE WERE NOTICED IN ONE SECTION OF THE CLEAR PVC TUBING AND STOPCOCK. NO OTHER TRACES OF ADHESIVE WERE NOTICED IN THE REMAINING SECTIONS OF THE TUBING OR STOPCOCK. DEVICE HISTORY RECORD (DHR) OF THE FINISH GOOD LOT #1141301 FOR COMPLAINT PR# (B)(4) WAS REVIEWED IN ORDER TO DETECT ANY ANOMALIES THAT COULD HAVE OCCURRED DURING THE INSPECTION AND MANUFACTURING PROCESS OF THE PRODUCT WHICH COULD HAVE CONTRIBUTED AND/OR BE RELATED WITH THE REPORTED CONDITION (PT LINE TUBING DETACHMENT) BEING INVESTIGATED. THE MANUFACTURING DATE OF FG LOT # 1141301 IS 2014-04 AND THE EXPIRATION DATE IS 2016-03. THE FG LOT #1141301 WAS RELEASED FOR DISTRIBUTION ON 06/19/2014 IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND INTEGRA REQUIREMENTS. NO ANOMALY OR DISCREPANCY WAS REPORTED DURING THE MANUFACTURE OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. A REVIEW OF COMPLAINT SYSTEM SINCE 2013 TO PRESENT, A TOTAL OF (B)(4) COMPLAINTS (INCLUDING THESE) RELATED TO THE REPORTED CONDITION (PT LINE TUBING DETACHMENTS) FOR LIMITORR FAMILY CATALOGS, (B)(4). BASED ON THE INFO PROVIDED BY THE CUSTOMER REGARDING PT LINE TUBING DETACHMENTS, A SUMMARY OF THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) IS PROVIDED BELOW FOR FURTHER EVAL OF THE COMPLAINT. "PRECAUTIONS: ALL LUER CONNECTIONS MUST BE CHECKED DURING PRIMING OF THE SYSTEM AND PRIOR TO CONNECTING TO THE PT. ENSURE THAT ALL CONNECTIONS ARE SECURE AND LEAK FREE." CONCLUSION: BASED ON THE DESCRIPTION OF THE EVENT REPORTED AND PRODUCT FAILURE ANALYSIS, THE REPORTED CONDITION (PT LINE TUBING DETACHMENT) WAS CONFIRMED. UPON EVAL OF THE UNIT, TRACES OF ADHESIVE WERE NOTICED IN ONE SECTION OF THE CLEAR PVC TUBING AND STOPCOCK. NO OTHER TRACES OF ADHESIVE WERE NOTICED IN THE REMAINING SECTIONS OF THE TUBING OR STOPCOCK. THEREFORE, BASED ON FAILURE ANALYSIS OF RETURNED UNIT, A POTENTIAL ROOT CAUSE MAY BE ATTRIBUTABLE TO THE BONDING METHOD USED FOR THE ASSEMBLY OF THE CLEAR PVC TUBING AND STOPCOCK.

    Description of Event or Problem · 1

    THE FIRST REPORT OF TWO INVOLVING THE SAME PRODUCT FROM THE SAME FACILITY. INS9020 LIMITORR VOLUME LIMITING EVD 20ML WAS REPORTED THAT THE GLUE GOT DISCONNECTED FROM THE LINE PAST THE PATIENT IV PORT. THE RESIDENT REPORTED THAT "THEY KEEP THEM IN MUCH LONGER THAN 5 DAYS SO HE SAID THE GLUE PROBABLY WOULD BE SATURATED AT THAT TIME. I ASKED HIM HOW MANY DAYS AND HE WOULDN'T SAY BUT DID SAY LONGER THAN FIVE DAYS. " ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353393 LIMITORR VOLUME LIMITING EVD 20 ML NA JXG INTEGRA NEUROSCIENCES PR 1141301

    Patients

    Seq Age Sex Outcome Treatment
    1