BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    MDR report key: 5978451 · Received September 26, 2016

    Report

    Report Number
    2648988-2016-00040
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K970658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 13 OCT 2016. THE INVESTIGATION INCLUDED: METHODS: -EVALUATION OF ACTUAL DEVICE. -REVIEW OF DEVICE HISTORY RECORDS. -REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: THE DEVICE WAS RECEIVED ON OCTOBER 5, 2016. THE CATHETER AND GUIDE WIRE WERE IN A PLASTIC BAG. THE CATHETER WAS TORN AND BROKEN AT DIFFERENT PLACES. THE UNRAVELING WAS OBSERVED IN THE SAME AREA WHERE THE CATHETER WAS TORN AND BROKEN. THE GUIDE WIRE WAS PULLED FROM THE CATHETER IN ORDER TO EVALUATE THE PORTION REMAINING INSIDE THE CATHETER. THE CATHETER CAME OUT WITH EASE. THE VISUAL INSPECTION SHOWED THAT THE PORTION THAT REMAINED INSIDE THE CATHETER WAS IN GOOD CONDITION. DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 1152267 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 APRIL 18, 2016. GUIDE WIRE WITH DISPENSER LOT USED WAS 3150216 (P/N 200398-001). INCOMING RECORDS FOR THE GUIDE WIRE WERE REVIEWED AND THEY WERE FOUND TO MEET CURRENT REQUIREMENTS. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM SEPTEMBER 2014 TO SEPTEMBER 2016, THERE ARE THREE (3) OTHER COMPLAINTS RELATED TO ¿GUIDE-WIRE SHREDDED¿. (B)(4). CONCLUSION: BASED ON INFORMATION RECEIVED FROM GTI (GUIDE-WIRE MANUFACTURER), THE MOST PROBABLE CAUSE FOR THE EVENT IS RELATED TO PRODUCT HANDLING BY THE FINAL USER.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE INS5010 HERMETIC LUMBAR CATHETER GUIDE WIRE SHREDDED AS IT WAS BEING REMOVED FROM THE CATHETER. THE DEVICE WAS BEING USED ON A MALE PATIENT. THERE WAS NOT PATIENT INJURY OR DEATH ALLEGED. A NEW CATHETER WAS PUT IN. THE INCIDENT LED TO A 15 MIN DELAY IN SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630034 HERMETIC LUMBAR CATHETER, CLOSED TIP N/A JXG INTEGRA NEUROSCIENCES PR 1152267

    Patients

    Seq Age Sex Outcome Treatment
    1