BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRAL DRAINAGE SET (IDS)

    MDR report key: 12636875 · Received October 14, 2021

    Report

    Report Number
    9612007-2021-00034
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 22, 2021
    Report Date
    November 24, 2021
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K924600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTEGRAL DRAINAGE SET (910410) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - THE DHR WAS REVIEWED AND DID NOT REVEAL ANY ANOMALY THAT COULD EXPLAIN THE REPORTED EVENT. FAILURE ANALYSIS - VISUAL INSPECTION REVEALED NO ANOMALY. A LEAK TEST WAS PERFORMED BUT DID NOT CONFIRM THE COMPLAINT: NO LEAK NOR WATER DROP CREATION WAS OBSERVED. AS SHOWN BY DEVICE HISTORY RECORDS REVIEW, RELEASED PRODUCTS PASSED TESTS AND CONTROLS, AT 100% DURING ASSEMBLY AND BY SAMPLING AT FINAL RELEASE. CONTROLS INCLUDE FUNCTIONAL TESTING: DIRECT LEAK TEST, REVERSE LEAK TEST. ROOT CAUSE - A LEAK TEST WAS PERFORMED BUT DID NOT CONFIRM THE COMPLAINT. COMPLAINT REPORTED A LEAK OF CSF IN SAMPLING CHAMBER AT THE LEVEL OF THE STOPCOCK: GIVEN THE RECEIVED DEVICE ANALYSIS, THE MOST LIKELY CAUSE OF THE REPORTED LEAK IS AN INSUFFICIENT SCREWING OF THE STOPCOCK ON THE LUER LOCK CONNECTOR. NO FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT DURING USE ON A PATIENT, LEAK OF CEREBROSPINAL FLUID (CSF) OCCURRED IN THE SAMPLING CHAMBER OF THE LEVEL OF THE STOPCOCK OF THE INTEGRAL DRAINAGE SET (910410). AS A RESULT, THE DEVICE WAS CHANGED WITHOUT ADVERSE PATIENT CONSEQUENCE. NO DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529538 INTEGRAL DRAINAGE SET (IDS) EXTERNAL DRAINAGE SYSTEMS JXG INTEGRA NEUROSCICENCS IMPLANTS SA 0222736

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown