BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE

    MDR report key: 5317216 · Received December 21, 2015

    Report

    Report Number
    2648988-2015-00081
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Report Date
    December 8, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 01/08/2016 . THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE REVIEW OF DEVICE HISTORY RECORDS REVIEW OF COMPLAINTS HISTORY RESULTS: ONE (1) USED UNIT FROM CATALOG SP0214, ¿ACCUDRAIN SPECIAL WITH ONE FOOT OF PROXIMAL PATIENT LINE¿ AND FINISH GOODS (FG) LOT # 1151078 WAS RECEIVED IN A POLYBAG ON 1/08/2016 UNIT WAS VISUALLY INSPECTED AND THE FOLLOWING OBSERVATIONS WERE NOTICED AT THE PANEL MOUNT STOPCOCK JUNCTION: THE PANEL MOUNT STOPCOCK WAS DETACHED FROM THE LOWER HANDLE MOUNT. AN EXTERNAL TRANSDUCER (NON ¿ INTEGRA PRODUCT) WAS ATTACHED TO THE STOPCOCK. ALTHOUGH SEVERAL ATTEMPTS WERE MADE TO UNFASTEN THE TRANSDUCER, IT WAS NOT POSSIBLE TO REMOVE THE TRANSDUCER FROM THE STOPCOCK. UPON FURTHER EVALUATION, TRACES OF ADHESIVE WERE NOTICED ALONG THE STOPCOCK AND GROOVES OF THE LOWER HANDLE MOUNT. DEVICE HISTORY RECORD (DHR) OF THE FINISH GOOD LOT # 1151078 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 (DETACHED STOPCOCK) BEING INVESTIGATED. THE MANUFACTURING DATE OF FG LOT # 1151078 IS 2015-04 AND THE EXPIRATION DATE IS 2017-03. THE FG LOT # 1151078 WAS RELEASED FOR DISTRIBUTION ON 04/27/2015 IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND INTEGRA REQUIREMENTS. NO ANOMALY OR DISCREPANCY WAS REPORTED DURING THE MANUFACTURING OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION (DETACHED STOPCOCK). NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR FG LOT 1151078 REGARDING A DETACHED PANEL MOUNT STOPCOCK OR ANY OTHER CONDITION. UPON REVIEW OF INTEGRA¿S COMPLAINT SYSTEM FROM 2013 ¿ DECEMBER 2015, ONLY ONE (1) COMPLAINT (INVESTIGATED UNDER THIS REPORT) FOR ACCUDRAIN FAMILY CATALOGS (CATALOGS: INS-8400, INS-8401, SP0213, SP0214, SP0215, SP0216, SP0217, SP0218, SP0219, SP0222, SP0226, SP0227, SP0233, SP0234, SP0235, SP0238) HAS BEEN RECEIVED CONCERNING A DETACHED PANEL MOUNT STOPCOCK. (B)(4) CONCLUSION: BASED ON PRODUCT FAILURE ANALYSIS, THE REPORTED CONDITION (STOPCOCK CAME UNDONE) WAS CONFIRMED WITH THE DETACHMENT OF THE STOPCOCK FROM THE PANEL MOUNT. 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 AND NCR'S HISTORY. NO INFORMATION WAS PROVIDED BY THE ACCOUNT REGARDING PRODUCT HANDLING DURING SYSTEM USE. ALTHOUGH A ROOT CAUSE FOR THE REPORTED CONDITION COULD NOT BE DETERMINED, IT MAY BE POSSIBLE THAT DETACHMENT FROM THE PANEL MOUNT OCCURRED AS A RESULT OF EXCESSIVE FORCE AND/OR INAPPROPRIATE HANDLING DURING TRANSDUCER MANIPULATION. AS PART OF THE MANUFACTURING PROCESS, CONTROLS ARE IN PLACE TO ENSURE CORRECT PRODUCT ASSEMBLY. 100% VISUAL INSPECTION OF LOWER HANDLE MOUNT SUB-ASSEMBLY PERFORMED BY MANUFACTURING PERSONNEL LOWER HANDLE MOUNT PULL TEST AND VISUAL INSPECTION PERFORMED TO RANDOM SAMPLES BY QUALITY CONTROL AT TWO DIFFERENT STAGES.

    Description of Event or Problem · 1

    THE PRODUCT INVOLVED WAS GIVEN TO THE INTEGRA SALES REPRESENTATIVE WHEN IT WAS REMOVED FROM THE PATIENT. THE STOPCOCK ON THE ACCUDRAIN CAME UNDONE AND A RUBBERBAND WAS NEEDED TO HOLD THE DRAIN TOGETHER. THERE WAS NO PATIENT ISSUE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841524 INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE N/A JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1