BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    MDR report key: 6515897 · Received April 24, 2017

    Report

    Report Number
    2648988-2017-00010
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    April 4, 2017
    Report Date
    April 5, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K922936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED (B)(6) 2017. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER. THE MANUFACTURING AND FINAL PACK PROCESSES RAN NORMALLY; NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THE PRODUCT. THIS LOT WAS RELEASED ON JUNE 09, 2016. GUIDE WIRE WITH DISPENSER LOT USED WAS 3150369 (P/N 200398-001). INCOMING RECORDS FOR THE GUIDE WIRE WERE REVIEWED AND THEY WERE FOUND TO MEET CURRENT REQUIREMENTS. NO RELATED SCAR, NCR OR CAPA WAS FOUND TO HAVE BEEN OPENED DURING THE PERIOD OF (B)(6) 2015 TO (B)(6) 2017. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM (B)(6) 2015 TO (B)(6) 2017, THERE ARE SIX (6) COMPLAINTS RELATED TO ¿GUIDE-WIRE STRIPPED¿. OUT OF THE SIX (6) COMPLAINTS, FIVE (5) WERE UNCONFIRMED. THE OTHER ONE, AS PER MANUFACTURER¿S (GUIDEWIRE TECHNOLOGIES) EVALUATION, IT WAS CONCLUDED TO BE MOST LIKELY CUSTOMER RELATED (EXCESSIVE FORCE). APPROXIMATELY 24,815 UNITS OF LUMBAR DRAINAGE CATHETER PRODUCT GROUP WERE RELEASED FOR DISTRIBUTION FROM (B)(6) 2015 TO (B)(6) 2017. THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS THEN 0.024%. SINCE NO PRODUCT WAS RETURNED, NO FURTHER EVALUATION IS POSSIBLE AT THIS MOMENT. THUS, THE ROOT CAUSE FOR THIS EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR AN INSERTION OF A LUMBAR DRAIN, THE INTRODUCER WIRE STRIPPED. THERE WAS NO PATIENT INJURY. DELAY IN SURGERY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 21APR2017 WITH THE FOLLOWING: A (B)(6) FEMALE PATIENT WITH AN UNDERLYING MEDICAL CONDITION OF ENCEPHALOCELE UNDERWENT A LEFT ENDOSCOPIC SINUS EXPLORATION, ENCEPHALOCELE WITH LUMBAR DRAIN INSERTION AND INJECTION UNDER FLUOROSCOPY ON (B)(6) 2017. NO CATHETER WAS PRE-SOAKED. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296660 HERMETIC LUMBAR CATHETER, CLOSED TIP N/A JXG INTEGRA NEUROSCIENCES PR 1161586

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR