BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE

    MDR report key: 5193012 · Received October 30, 2015

    Report

    Report Number
    2648988-2015-00075
    Event Type
    Injury
    Date Received
    October 30, 2015
    Report Date
    October 12, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 03 NOV 2015: IT WAS A FEMALE PATIENT. THE LEAK WAS BROUGHT TO THE ATTENTION OF THE BEDSIDE REGISTERED NURSE (RN) WHEN THE PATIENT COMPLAINED OF A SEVERE HEADACHE, WHICH WAS NEW FOR HER. THE LEAKAGE ON THE PATIENT'S GOWN WAS CONSISTENT WITH MAYBE 20 TO 30 MILLILITERS (ML) OF DRAINAGE. THE PATIENT WAS NOT BEING MOVED, NOR HAD SHE BEEN RECENTLY MOVED. THE LAST MOVEMENT, FROM CHAIR TO BED, HAD BEEN SEVERAL HOURS AGO. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 18 NOV 2015: THE COMPLAINT UNIT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) OF THE FINISH GOOD LOT # 1151601 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 (LEAK AT LUER LOCK SITE) BEING INVESTIGATED. THE MANUFACTURING DATE OF FG LOT # 1151601 IS 2015-05 AND THE EXPIRATION DATE IS 2017-04. THE FG LOT # 1151601 WAS RELEASED FOR DISTRIBUTION ON 06/11/2015 IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND INTEGRA REQUIREMENTS. NO ANOMALY OR DISCREPANCY WAS REPORTED DURING THE LEAK TESTS OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. NO MANUFACTURING REWORKS WERE ISSUED TO FG LOT # 1151601 FOR LEAKAGE OR ANY OTHER CONDITION. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR FG LOT 1151601 REGARDING LEAKAGE AT LUER LOCK SITE OR ANY OTHER CONDITION. THE COMPLAINT OCCURRENCE RATE OS APPROXIMATELY (B)(4). GIVEN THAT THE COMPLAINT UNIT WAS NOT RETUNED FOR EVALUATION, THE REPORTED CONDITION (LEAK AT LUER LOCK SITE) COULD NOT BE CONFIRMED. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS WERE DETERMINED.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/18/2015. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR FG LOT 1151601 REGARDING LEAKAGE AT LUER LOCK SITE OR ANY OTHER CONDITION. APPROXIMATELY (B)(4) UNITS OF ACCUDRAIN DEVICES HAVE BEEN SHIPPED FOR DISTRIBUTION FROM 2013 ¿ OCTOBER 20, 2015, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). CONCLUSION: GIVEN THAT THE COMPLAINT UNIT WAS NOT RETUNED FOR EVALUATION, THE REPORTED CONDITION (LEAK AT LUER LOCK SITE) COULD NOT BE CONFIRMED. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS WERE DETERMINED BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD (DHR), CAPA'S, NCR'S AND SCAR'S HISTORY. AS PART OF THE MANUFACTURING PROCESS, CONTROLS ARE IN PLACE TO DETECT LEAKAGE ALONG THE PATIENT LINE OF THE DRAINAGE SYSTEM. 100% ASSEMBLY LEAK TEST IS PERFORMED BY MANUFACTURING PERSONNEL AND A SAMPLING IS PERFORMED BY QUALITY CONTROL INSPECTION. IT WAS INDICATED IN THE COMPLAINT RECORD THAT THE ACCUDRAIN HAD BEEN IN USE FOR SEVERAL DAYS DURING WHICH THE PRODUCT WAS PERFORMING AS EXPECTED WITH NO REPORTED INCIDENCE OF LEAKAGE. ALSO, THE LAST MOVEMENT FROM CHAIR TO BED HAD TAKEN PLACE SEVERAL HOURS BEFORE THE LEAKAGE WAS NOTICED. ALL INTEGRA ACCUDRAIN DRAINAGE SYSTEMS ARE DESIGNED TO CONNECT TO ANY ONE OF THE INTEGRA VENTRICULAR AND LUMBAR CATHETERS VIA A LUER CONNECTOR INCLUDED WITH THE ACCUDRAIN OR INTEGRA CATHETER KIT. FROM THE INFORMATION PROVIDED IN THE COMPLAINT RECORD, IT IS UNKNOWN IF AN INTEGRA LUER CONNECTOR WAS USED TO CONNECT THE CATHETER TO THE MALE LUER LOCK OF THE ACCUDRAIN. INTEGRA MAKES NO CLAIM AS TO THE PERFORMANCE OF THE PRODUCT IF IT IS USED IN CONJUNCTION WITH COMPONENTS OF OTHER MANUFACTURERS. ASSUMING AN INTEGRA LUER CONNECTOR WAS USED, IT MAY BE POSSIBLE THAT AN INADVERTENT BENT/PULL AT THE LUER LOCK SITE IMPAIRED THE CONNECTION BETWEEN THE MALE LUER LOCK AND CATHETER CONNECTOR RESULTING IN THE REPORTED LEAKAGE. IN THE EVENT THAT UNIT IS RECEIVED, THIS SECTION WILL BE UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE SYSTEM HAD BEEN IN USE FOR SEVERAL DAYS WITHOUT ANY ISSUES AND THEN THE NURSE NOTED A WET SPOT ON THE PATIENT'S GOWN. THE SYSTEM WAS LEAKING CEREBROSPINAL FLUID (CSF) AT THE LEUR LOCK SITE WHERE THE SYSTEM ATTACHES TO THE EXTERNAL VENTRICULAR DRAIN (EVD) CATHETER. THE LOCK WAS FULLY TIGHT. THE CATHETER WAS CLIPPED AND A NEW DRAINAGE SYSTEM WAS REATTACHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720893 ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR 1151601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other