BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUDRAIN WITH ANTI-REFLUX VALVE

    MDR report key: 6069067 · Received November 1, 2016

    Report

    Report Number
    2648988-2016-00046
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 26JAN2017: THE CUSTOMER REPORTED THAT FOR ICU PATIENTS WITH A HUMMINGBIRD OR EVD (DRAIN), COLLODION REMOVER OR ACETONE IS USED TO REMOVE THE COLLODION GEL THAT IS USED TO GLUE ELECTROENCEPHALOGRAM (EEG) LEADS (ELECTRODES) TO A PATIENT¿S HEAD. WHEN ANY OF THESE SUBSTANCES COME IN CONTACT WITH THE STOPCOCK, THEY CAUSE IT TO CRACK WITHIN SECONDS OF APPLYING. THEY TRIED THE SAME THING WITH ACETONE AND IT TOOK A LITTLE LONGER BUT EVENTUALLY IT CRACKED AND BROKE IN HALF. THE CUSTOMER STATED SHE REVIEWED THE PICTURES OF THE CRACKS IN THE DRAIN SHE SENT BACK FOR EVALUATION AND THE DRAIN THEY HAD USED TO TEST THE SOLUTIONS AND THEY LOOKED IDENTICAL. SHE BELIEVED THAT THERE WAS NOT A DEFECT IN THE DRAIN BUT RATHER AN OBVIOUS INCOMPATIBILITY WITH THE MATERIALS OF THE DRAIN AND COLLODION REMOVER AND/OR ACETONE. IT WAS BELIEVED THE SUBSTANCE ENDED UP ON THE DRAIN BECAUSE OF THE WAY THE DRAIN IS SECURED TO THE PATIENT'S SHOULDER AND THE EEG THAT COMPLETELY COVERS THE SCALP AND SIDE OF THE FACE WHICH CAUSES THE TWO TO BE WITHIN CLOSE PROXIMITY. THE EEG TEAM AT (B)(6) WILL NOW BE TRIALING A DIFFERENT METHOD OF GLUING THE EEG LEADS THAT IS SUPPOSED TO BE REMOVABLE WITH SOAP AND WATER/WATERLESS SHAMPOO. THEY STATED THE NEED TO DISCONTINUE USE OF COLLODION REMOVER AND ACETONE IN THE ICU FOR PATIENTS WITH A HUMMINGBIRD OR EVD (DRAIN) OF THE BRAIN IMMEDIATELY. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 03FEB2017. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO EVIDENCE OF THE BROKEN DEVICE WAS PROVIDED FOR THIS COMPLAINT. AS REPORTED BY THE HOSPITAL, THE DEVICE WAS DISCARDED. DHR REVIEW WAS NOT POSSIBLE SINCE THE CUSTOMER DID NOT REPORT THE DEVICE¿S LOT NUMBER. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM OCTOBER 2014 TO OCTOBER 2016, THERE ARE FIVE (5) COMPLAINTS (INCLUDING THESE TWO (2)) RELATED TO ¿BROKEN/CRACKED STOPCOCK¿. THIS LOT NUMBER (1161828) HAS NOT BEEN REPORTED IN ANY OTHER COMPLAINT. THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS (B)(4). CONCLUSION: ORIGINALLY, IT WAS CONCLUDED THAT THERE ARE CONTROLS AT INTEGRA TO DETECT THIS DEFECT AND THAT NO MANUFACTURING EVENT WAS NOTICED THAT COULD PROVOKE STOPCOCK BREAKAGE. IT WAS ALSO STATED THAT THE DEVICE SET-UP, HANDLING, OR CIRCUMSTANCES SURROUNDING BREAKAGE OF THE DEVICE WERE NOT EXPLAINED IN THESE COMPLAINTS OR THE AMOUNT OF TIME IN USE PRIOR TO BREAKAGE. IN THREE (3) OUT OF THE FOUR (4) COMPLAINTS, THE FAILURE WAS REPORTED TO HAPPEN WHILE IN USE, NOT BROKEN WHEN ORIGINALLY PLACED; THE OTHER ONE WAS NOT EXPLICIT. IT WAS ALSO NOTICED THAT TRENDING DID NOT SHOW THAT THERE WAS A SPIKE IN STOPCOCK BREAKAGE IN THE MARKET AND THUS SEEMED TO BE ISOLATED TO THE (B)(6) AND THAT THESE BREAKAGES COULD HAVE BEEN PROVOKED BY SOME INTERNAL PRACTICE OR HANDLING OF THE DEVICE. NEW INFORMATION WAS SHARED BY THE CUSTOMER STATING THAT COLLODION REMOVER OR ACETONE IS USED TO REMOVE THE COLLODION GEL THAT IS USED TO GLUE ELECTROENCEPHALOGRAM (EEG) LEADS (ELECTRODES) TO A PATIENT¿S HEAD. WHEN ANY OF THESE SUBSTANCES COME IN CONTACT WITH THE STOPCOCK, THEY CAUSE IT TO CRACK. THEREFORE THE ORIGINAL CONCLUSION REGARDING THAT MOST PROBABLE CAUSE COULD BE LINKED TO SOME INTERNAL HOSPITAL PRACTICE WAS ACCURATE.

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 11/11/2016. THE INVESTIGATION INCLUDED: METHOD: - DHR REVIEW. -TREND ANALYSIS. RESULTS: DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 1161828 WAS REVIEWED. THE MANUFACTURING AND FINAL PACK PROCESSES RAN NORMALLY; NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THE PRODUCT. THIS LOT WAS RELEASED ON JUNE 01, 2016. STOPCOCK LOT USED FOR THIS LOT WAS 3152879 (P/N 200407-001). INCOMING RECORDS FOR THE STOPCOCK WERE REVIEWED AND THEY WERE FOUND TO MEET CURRENT REQUIREMENTS. REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM OCTOBER 2014 TO OCTOBER 2016, (B)(4). THE DEVICE HAS NOT BEEN RECEIVED, HOWEVER, PICTURES OF THE DEVICE WERE PROVIDED; THUS, CONFIRMING THE FAILURE FOR COMPLAINT. THE PICTURE SHOWS WHAT APPEARS TO BE A BROKEN/MISSING PIECE OF THE STOPCOCK BOTTOM PART (NOT JUST CRACKED), SUGGESTING THAT IT RECEIVED A HIT OR BLOW. CONCLUSION: IN CONCLUSION, THERE ARE PROCEDURAL CONTROLS IN PLACE TO DETECT AND PREVENT THIS KIND OF DEFECT. THE WAY THIS STOPCOCK IS BROKEN, IT WOULD BE DIFFICULT TO MISS DURING INCOMING INSPECTION OR DURING ASSEMBLY AND INSPECTIONS PERFORMED DURING MANUFACTURING OPERATIONS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR LOT 1161828. THE MOST PROBABLE CAUSE FOR THE BREAKAGE APPEARS TO BE DUE TO AN UNINTENDED BLOW/ HIT DURING PRODUCT HANDLING OUTSIDE OF INTEGRA¿S CONTROL.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PRODUCT ID, SAME LOT NUMBER, SAME PRODUCT PROBLEM, DIFFERENT PATIENTS). THIS REPORT IS IN REGARDS TO THE SECOND PATIENT. LINKED TO MFG REPORT: 2648988-2016-00045. ON (B)(6) 2016, THE INS8401 ACCUDRAIN WITH ANTI-REFLUX VALVE WAS FOUND TO HAVE A STOP COCK, PROXIMAL TO THE PATIENT, TO BE CRACKED AND LEAKING CEREBROSPINAL FLUID (CSF). THE ENTIRE BOTTOM OF THE STOP COCK WAS CRACKED AND ALL UP THE SIDES. IT WAS UNKNOWN IF THERE WAS PATIENT INJURY. THE DEVICE WAS REMOVED AND THE PATIENT WAS PLACED UNDER MENINGITIS WATCH WITH ANTIBIOTICS POSSIBLE. THE USER FACILITY HAD TWO ACCUDRAIN'S CRACK IN THIS SAME MANNER WITHIN DAYS OF EACH OTHER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721913 ACCUDRAIN WITH ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR 1161828

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R