BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF DRAINAGE SYSTEM W/BLUE STRIPE TUBING & 1-WAY

    MDR report key: 8780838 · Received July 11, 2019

    Report

    Report Number
    2648988-2019-00076
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 6, 2019
    Report Date
    June 19, 2019
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K972994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 10 JULY 2019: THE DEVICE WAS USED FOR CEREBROSPINAL FLUID (CSF) DRAINAGE. NO SAMPLE WAS RECEIVED FOR FAILURE ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALY WAS REPORTED DURING THE MANUFACTURING AND PACKAGING PROCESSES THAT CAN BE ASSOCIATED TO THE REPORTED CONDITION. THE COMPLAINT COULD NOT BE CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 0

    ONE INS8600 UNIT WAS RECEIVED AND IT WAS OBSERVED THAT THE LAST SEGMENT OF THE PATIENT LINE (DISTAL TO THE DEVICE) HAD BEEN MARKED WITH BLACK INK. WATER WAS PASSED THROUGH THE PATIENT LINE AND TWO (2) LEAKS WERE OBSERVED. THESE WERE AT EACH SIDE OF THE MARKED AREA MENTIONED BEFORE. BOTH LEAKS WERE AT THE CONNECTION OF THE BLUE STRIPE, LENGTH 10 CM TUBING (P/N 400438-001) WITH THE TWO (2) MALE LUER LOCK PORT 145 OD TUBE, RIGID PVC (P/N 200395-001) AT EACH END OF THE TUBE. BOTH LEAK SITES WERE INSPECTED UNDER MAGNIFICATION AND IT WAS CONFIRMED THAT ADHESIVE HAD BEEN APPLIED TO THE TUBING/LUER LOCK PORT CONNECTION. THERE WAS A THIRD MALE LUER LOCK (P/N 200395-001) IN THE PATIENT LINE, BUT THIS ONE DID NOT LEAK. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE FOR THIS EVENT WAS UNKNOWN; NONETHELESS, A TRAINING WAS PROVIDED TO THE MANUFACTURING AND QA PERSONNEL TO MAKE THEM AWARE OF THE EVENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE INS8600 CSF DRAINAGE SYSTEM WAS USED FOR BLOOD EVACUATION ON (B)(6) YEAR OLD FEMALE PATIENT, A HOLE IN THE TUBING WAS DISCOVERED ON (B)(6) 2019. THERE WAS NO CLINICAL CONSEQUENCE REPORTED. THE DRAINAGE SYSTEM WAS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577069 CSF DRAINAGE SYSTEM W/BLUE STRIPE TUBING & 1-WAY N/A JXG INTEGRA NEUROSCIENCES PR 3261613

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR