BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL EVD 10-110 W/O Y SITE

    MDR report key: 6122875 · Received November 22, 2016

    Report

    Report Number
    2648988-2016-00053
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Report Date
    November 7, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K920156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON MAY 10, 2017. RESULTS: EVALUATION OF RETURNED DEVICE; MONITORR UNIT WAS RECEIVED WITH A TRANSDUCER OF AN UNKNOWN MANUFACTURER. THE UNIT WAS VISUALLY INSPECTED AND WAS FOUND TO BE IN GOOD CONDITION. THE MANIFOLD STOPCOCK WAS VERIFIED AND PHOTOGRAPHED: ALL WERE FOUND IN PERFECT CONDITION. NO DEFECTS WERE DETECTED DURING THE PRODUCT INSPECTION. THE MONITORR STOPCOCK HAS NO MOVING PARTS. STOPCOCKS USED ARE STANDARD OFF THE SHELF PRODUCTS. THE STOPCOCK¿S LUER THREADS WERE VERIFIED AND NO DEFECT WAS DETECTED. THE COMPLAINT IS CONSIDERED NOT CONFIRMED SINCE THE CONDITION WHERE THE TRANSDUCER WOULD FALL OFF WITHOUT EXTERNAL INTERVENTION COULD NOT BE REPRODUCED AND THE ONLY WAY EVIDENCED FOR THE TWO COMPONENTS TO SEPARATE WOULD BE AS THE RESULT OF CONTINUOUS OR REPETITIVE HANDLING. DHR REVIEW; THE MANUFACTURING AND FINAL PACK PROCESSES RAN NORMALLY; NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THE PRODUCT. AFTER VERIFYING THAT THE LOT MET ALL ESTABLISHED REQUIREMENTS, THIS LOT WAS RELEASED ON AUGUST 03, 2016. THE STOPCOCK TO WHICH THE TRANSDUCER IS CONNECTED WAS PART NUMBER 2058-001 / LOT 3160481. RELEASE RECORDS WERE EVALUATED AND NO DEVIATIONS WERE NOTED. THE LOT IS RELEASED BASED ON MANUFACTURER CERTIFICATION OF COMPLIANCE. NOTHING UNUSUAL WAS NOTICED IN THE DHR REVIEW THAT COULD HAVE CAUSED THE REPORTED EVENT. COMPLAINTS HISTORY; UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM NOVEMBER 2014 TO NOVEMBER 2016, THERE ARE EIGHT (8) COMPLAINTS (INCLUDING THESE ONES) RELATED TO ¿TRANSDUCER DISCONNECTION¿ FOR THE FOR EXTERNAL DRAINAGE (MONITORR) PRODUCT FAMILY. APPROXIMATELY (B)(4) UNITS WERE RELEASED FOR DISTRIBUTION FROM NOVEMBER 2014 TO NOVEMBER 2016. THEREFORE, THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS (B)(4). CONCLUSION: THE CONDITION WHERE THE TRANSDUCER WOULD FALL OFF WITHOUT EXTERNAL INTERVENTION COULD NOT BE REPRODUCED. NO DEFECT WAS FOUND ON THE STOPCOCK OF THE MONITORR. NO EVIDENCE WAS FOUND THAT THE DEVICE IS THE CAUSE OF THE REPORTED EVENT. THE ROOT CAUSE IS CONSIDERED UNDETERMINED (ALTHOUGH IT COULD BE RELATED TO THE TRANSDUCER OR HANDLING).

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12/06/2016. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO SAMPLE OR PHOTO HAS BEEN RECEIVED FOR THIS COMPLAINT AT THE TIME OF THIS INVESTIGATION; THUS, COULD NOT BE CONFIRMED. DHR REVIEW WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM NOVEMBER 2014 TO NOVEMBER 2016, THERE ARE EIGHT (8) COMPLAINTS (INCLUDING THESE ONES) RELATED TO ¿TRANSDUCER DISCONNECTION¿ FOR THE FOR EXTERNAL DRAINAGE (MONITORR) PRODUCT FAMILY. AT THE MOMENT ALL OF THE COMPLAINTS ARE FROM THE SAME FACILITY. A DEVICE AND A TRANSDUCER WERE RETURNED FOR (B)(4) AND THE COMPLAINT COULD NOT BE DUPLICATED, THUS IT WAS NOT CONFIRMED. MONITORR'S CONNECTING STOPCOCK WAS IN GOOD STATE, NO DEFECT WAS DETECTED. NO OTHER DEVICE HAS BEEN RETURNED FOR EVALUATION. SO FAR NO DEFECTS HAVE BEEN DETECTED ON THE MONITORR EVD DEVICE THAT COULD CAUSE THE DISCONNECTION EVENTS. THE SITUATION MAY BE RELATED TO THE TRANSDUCER USED OR USER RELATED. THE CLIENT HASN¿T DISCLOSED INFORMATION REGARDING THE PROCEDURE USED TO ATTACH THE TRANSDUCERS (SET-UP), OR IF THE EVENTS ARE ISOLATED TO CERTAIN USERS ONLY. THE CLIENT INFORMED OUR CLINICAL SALES/ CLINICAL EDUCATION SPECIALIST THAT THEY ARE EVALUATING OTHER TRANSDUCERS TO USE WITH PRODUCT. (B)(4). CONCLUSION: NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES SURROUNDING THESE EVENTS, ONLY THAT THE TRANSDUCERS DISCONNECT FROM THE DRAINS. THE TRANSDUCER MAY BE ATTACHED AT ANY OF TWO LOCATIONS, AS PER IFU: ¿A PRESSURE TRANSDUCER MAY BE ATTACHED PROXIMATE TO THE PATIENT AT THE PATIENT LINE STOPCOCK OR AT THE MANIFOLD STOPCOCK FOR RIGID MOUNTING WITH THE POLE MOUNTED BRACKET ASSEMBLY.¿ THE COMPLAINT DOES NOT INFORM FOR HOW LONG WAS IT CONNECTED (PRIOR DISCONNECTION), IT DOESN¿T SAY IF THE STOPCOCK¿S WAS DEFECTIVE OR BROKEN, OR IF THE TRANSDUCER¿S CONNECTOR WAS EXAMINED FOR DEFECTS. A POSSIBLE CAUSE MAY BE THAT THE LUER LOCK WAS NOT PROPERLY TIGHTENED. USER MUST ENSURE THAT THE TRANSDUCER (IF FROM A DIFFERENT MANUFACTURER) USED IS COMPATIBLE WITH INTEGRA¿S DEVICE AND THAT A SECURE CONNECTION IS POSSIBLE. NO DEFECTS HAVE BEEN DETECTED ON THE MONITORR EVD PRODUCT THAT COULD CAUSE THE DISCONNECTION EVENTS. THE SITUATION MAY BE RELATED TO THE TRANSDUCER USED OR USER RELATED. THE CLIENT HASN¿T DISCLOSED INFORMATION REGARDING THE PROCEDURE USED TO ATTACH THE TRANSDUCERS (SET-UP), OR IF THE EVENTS ARE ISOLATED TO CERTAIN USERS ONLY. THE CLIENT INFORMED OUR CLINICAL SALES/ CLINICAL EDUCATION SPECIALIST THAT THEY ARE EVALUATING OTHER TRANSDUCERS TO USE WITH PRODUCT. LOT AND CATALOG NUMBERS FOR THE DEVICE INVOLVED IN THIS EVENT ARE UNKNOWN. NO DEVICE HAS BEEN RETURNED FOR EVALUATION AND IT IS UNCERTAIN IF THE DEVICE WILL BE RETURNED. FURTHER INVESTIGATION IS NOT POSSIBLE.

    Description of Event or Problem · 1

    THIS IS THE FOURTH OF FIVE REPORTS (SAME PRODUCT, SAME PRODUCT PROBLEM, SAME FACILITY). THE MONITOR DRAIN TRANSDUCER WAS DISCONNECTING FROM THE DRAIN. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. LINKED TO MFR REPORT: 2648988-2016-00051, 2648988-2016-00052, 2648988-2016-00055, 2648988-2016-00054.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771595 SPECIAL EVD 10-110 W/O Y SITE N/A JXG INTEGRA NEUROSCIENCES PR 1163040

    Patients

    Seq Age Sex Outcome Treatment
    1