BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE

    MDR report key: 6987928 · Received October 30, 2017

    Report

    Report Number
    2648988-2017-00049
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Report Date
    October 9, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 12/06/2017. TWO (2) ACCUDRAIN UNITS WERE RETURNED FOR EVALUATION. BOTH UNITS HAD THE SAME LOT NUMBER 1170274. THIS LOT NUMBER WAS DIFFERENT THAN THE ONES REPORTED IN THE COMPLAINT. AS PER COMPLAINT COMMUNICATIONS, THE LOT NUMBERS ORIGINALLY REPORTED (1170743 AND 1170275) WERE THE ONES AVAILABLE AT THE FACILITY¿S STOCK, BUT THE ACTUAL LOT NUMBER(S) OF THE INVOLVED UNITS WAS UNKNOWN. THE REPORTED FAILURE WAS EVIDENT IN TWO (2) UNITS RETURNED: THE ZERO-REFERENCE WAS DETACHED FROM THE STOPCOCK HOLDER ON THE LOWER HANDLE MOUNT. THE FOLLOWING WAS OBSERVED: TRANSDUCER (FOR ICP MONITORING) WAS PRESENT IN BOTH SAMPLES RETURNED. ONE OF THE UNITS STILL HAD THE TRANSDUCER ATTACHED TO THE ZERO-REFERENCE STOPCOCK. ON THE OTHER SAMPLE, THE TRANSDUCER WAS INCLUDED BUT WAS LOOSE IN THE PACKAGE. BOTH ZERO-REFERENCE STOPCOCKS WERE INSPECTED TO EVALUATE IF THEY WERE BROKEN: BOTH ZERO-REFERENCE STOPCOCKS WERE INTACT ¿ NO CSF PATHWAY BREACH WAS EVIDENCED. UPON MAGNIFICATION, IT WAS EVIDENCED THAT ADHESIVE WAS APPLIED ON THE THREE GROOVES OF THE STOPCOCK HOLDER ON THE LOWER HANDLE MOUNT AS INDICATED IN THE MANUFACTURING SHOP ORDER INSTRUCTIONS EVALUATION OF THE RETURNED UNITS CONFIRMED THAT ADHESIVE WAS APPLIED AS PER MANUFACTURING INSTRUCTIONS. ADHESIVE WAS PRESENT ON THE THREE GROOVES OF THE STOPCOCK HOLDER; ALSO, THERE WAS EVIDENCE OF ADHESIVE PRESENCE ON THE STOPCOCKS. DEVICE MANUFACTURING RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER AND THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE HISTORY RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS WERE FOUND. THE ROOT CAUSE FOR THIS EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    STOPCOCK WAS DISCONNECTING FROM THE LIGHT BLUE HOUSING ON THE BASE OF THE ACCUDRAIN WHERE THE TRANSDUCER WOULD BE ATTACHED. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THERE WAS NO REVISION/ MEDICAL INTERVENTION REQUIRED. THE CUSTOMER HAS ESTIMATED THIS ISSUE HAS HAPPENED ON 4 UNITS, BUT ONLY HAS TWO TO RETURN. ACCORDING TO THE ASSOCIATE NURSE MANAGER, HE COULD NOT SAY FOR SURE IF THE LOT NUMBERS REPORTED WERE THE SAME AS THE DRAINS THAT WERE BROKEN. THE LOT NUMBERS REPORTED ARE THE ONLY TWO THAT WERE ON THEIR SHELVES. LINKED TO MFG. REPORT NUMBERS: 2648988-2017-00050, 2648988-2017-00051, 2648988-2017-00052.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766395 ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR 1170275

    Patients

    Seq Age Sex Outcome Treatment
    1