BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULAR CATHETER ACCESSORY KIT (VCAK)

    MDR report key: 5656469 · Received May 16, 2016

    Report

    Report Number
    9612007-2016-00010
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Report Date
    May 3, 2016
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K914995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 09SEP2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: TWO BOXES OF VCAK REF 951303, LOT 193318 WERE RECEIVED: BOXES ARE DAMAGED AND FEATURE TRACES INDICATING THEY HAVE BEEN WET. ONE OF THE IFU INSIDE THE BOX ALSO FEATURED TRACES INDICATING THEY HAVE BEEN WET. BOTH OUTER AND INNER PACKAGING SHOW SIGNS OF HAVING BEEN DAMP. MANUFACTURING PROCESS INCLUDE SEVERAL STEPS ENSURING DAMAGED BOXES CANNOT BE USED: INSPECTION DURING PACKAGING STEP AND AFTER STERILIZATION, PRIOR TO SHIPMENT TO THE DISTRIBUTION CENTERS. THE DEVICE HISTORY RECORDS OF THE VCAK REF 951303, LOT 193318 WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. THE BATCH INCLUDED (B)(4) PRODUCTS AND WAS MANUFACTURED IN JANUARY 2016. NO SIMILAR COMPLAINT WAS RECEIVED FOR A PRODUCT FROM THIS BATCH REVIEW OF INTEGRA¿S COMPLAINT SYSTEM FROM JANUARY 2013 TO MAY 13, 2016 FOR VCAK REF 951303, SHOWS NO SIMILAR COMPLAINT. APPROXIMATELY (B)(4) UNITS OF VCAK HAVE BEEN SOLD FROM 2013 TO MARCH 2016, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). THE COMPLAINT WAS TRANSMITTED TO THE DISTRIBUTION CENTER: (B)(4). THE PACKAGE CONTAINING 951303, LOT 193318 SUSTAINS WATER DAMAGE WHILE IN TRANSIT FROM THE (B)(4) TO THE CUSTOMER. THE TYPE THE WATER DAMAGE MENTIONED WOULDN¿T GOT THROUGH THE PICK, PACK AND SHIP PROCESS THAT ARE IN PLACE AT THE (B)(4). THE COMPLAINT IS VERIFIED BUT IT IS UNLIKELY THAT THE PRODUCTS BE SHIPPED FROM THE MANUFACTURING SITE IN SUCH A DAMAGED STATE. THE MOST LIKELY CAUSE IS A DAMAGE DURING THE SHIPMENT TO THE HOSPITAL. NO FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED AT THE MANUFACTURING SITE

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE INNER PACKAGE OF THE TWO OF THE DEVICES WERE WET/DAMP. THERE WAS NO EXTERNAL DAMAGE. THERE WAS NO PATIENT PREPPED FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313430 VENTRICULAR CATHETER ACCESSORY KIT (VCAK) EXTERNAL DRAINAGE ACCESSORIES JXG INTEGRA NEUROSCICENCS IMPLANTS SA

    Patients

    Seq Age Sex Outcome Treatment
    1