BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURAWRAP NERVE PROTECTOR 10MM ID X 4CM LENGTH

    MDR report key: 5964990 · Received September 20, 2016

    Report

    Report Number
    1121308-2016-00019
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    June 1, 2016
    Report Date
    July 12, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    JXI
    PMA / PMN Number
    K041620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL AND EMAIL WITH CURRENT SALES REP 3OCT2016: THE INCORRECT LOT NUMBER (LOT # 1140388) WAS MISS-TRANSCRIBED ON A DUPLICATE SALES ORDER BY THE SALES REPRESENTATIVE. THE HOSPITAL HAS A ¿HARD CONSIGNMENT¿ AGREEMENT WHERE REPLACEMENT PRODUCT IS DIRECTLY REQUESTED BY THE HOSPITAL OF CUSTOMER SERVICE. THOSE RECORDS HAVE THE CORRECT LOT # FOR THE PRODUCT USED IN THIS EVENT, LOT# 1150180, WHICH WAS NOT EXPIRED AT THE TIME OF IMPLANTATION. THE DUPLICATE SALES ORDER WAS CREATED IN ERROR. NO EXPIRED PRODUCT WAS IMPLANTED. INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 1NOV2016. THE INVESTIGATION INCLUDED: METHOD: - REVIEW OF DEVICE HISTORY RECORDS. - REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: ALTHOUGH THE PRODUCT WAS NOT IMPLANTED EXPIRED AS PER NEW INFORMATION RECEIVED ON OCTOBER 03, 2016, THE MANUFACTURING PROCESS OF FINISHED GOOD LOT 1150180 WAS REVIEWED. FINISHED GOODS (FG) LOT 1150180 WAS RELEASED ON 02/11/15 AND ITS EXPIRATION DATE IS 2017-01. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESS OF THIS LOT THAT COULD BE RELATED TO THE INITIAL REPORTED CONDITION. NO PATIENT HARM WAS REPORTED AS PART OF THIS INCIDENT SINCE NO EXPIRED PRODUCT WAS IMPLANTED AND NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THIS FG LOT 1150180. A REVIEW OF COMPLAINT SYSTEM IS NOT NECESSARY AT THIS TIME SINCE ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED ON OCTOBER 03, 2016 THERE WAS NO EXPIRED DEVICE IMPLANTED. CONCLUSION: THE ROOT CAUSE IS RELATED TO THE MISS-TRANSCRIBED LOT NUMBER 1140388 INSTEAD OF LOT NUMBER 1150180 ON A DUPLICATE SALES ORDER BY THE SALES REPRESENTATIVE AT THE REPORTING FACILITY. BASED ON THE ADDITIONAL INFORMATION PROVIDED ON THE COMPLAINT RECORD ON OCTOBER 03, 2016 (NO EXPIRED PRODUCT WAS IMPLANTED) AND THE FAILURE ANALYSIS THAT WAS MADE TAKING INTO ACCOUNT THE RETAIN SAMPLES EVALUATION, THE INITIAL REPORTED INCIDENT (EXPIRED PRODUCT) COULD NOT BE ASSOCIATED TO THE MANUFACTURING / PACKAGING PROCESS PERFORMED. COMPLAINT UNIT WAS LABELED IN AN ACCURATE MANNER AND APPLICABLE PROCEDURES WERE FOLLOWED. THE PACKAGED PRODUCT HAD SEVERAL LABELS THAT CONTAINED THE EXPIRATION DATE THAT ARE VERY NOTICEABLE BY THE END USER.

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 16SEP2016. THE INVESTIGATION INCLUDED: METHOD: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESS OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. FINISHED GOODS (FG) LOT 1140388 WAS RELEASED ON 02/28/14 AND ITS EXPIRATION DATE IS 2016-02. A REVIEW OF THE ELECTRONIC DATABASE FROM 02/06/14 UNTIL 08/19/16, FOUND THREE (3) COMPLAINTS (INCLUDING THE ONE BEING INVESTIGATED) RELATED TO ¿EXPIRED PRODUCT¿ HAVE BEEN REPORTED IN THE NEURAWRAP FAMILY AT INTEGRA LIFESCIENCES (B)(4) FACILITY. APPROXIMATELY (B)(4) UNITS OF NEURAWRAP PRODUCTS HAVE BEEN SHIPPED FOR SALES PURPOSES SINCE 02/06/14 UNTIL 08/19/16, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). NO SIMILAR COMPLAINTS RELATED TO ¿EXPIRED PRODUCT¿ HAVE BEEN REPORTED FOR THIS FG LOT 1140388. CONCLUSION: BASED ON INFORMATION PROVIDED ON THE COMPLAINT RECORD AND THE FAILURE ANALYSIS THAT WAS MADE TAKING INTO ACCOUNT THE RETAIN SAMPLES EVALUATION, THE REPORTED INCIDENT (EXPIRED PRODUCT) COULD NOT BE ASSOCIATED (CONFIRMED) TO THE MANUFACTURING / PACKAGING PROCESS PERFORMED AT INTEGRA (B)(4). COMPLAINT UNIT WAS LABELED IN AN ACCURATE MANNER AND APPLICABLE PROCEDURES. THE PACKAGED PRODUCT HAD SEVERAL LABELS THAT CONTAINED THE EXPIRATION DATE THAT ARE VERY NOTICEABLE BY THE END USER, THEREFORE THE REPORTED INCIDENT COULD BE ASSOCIATED TO THE HANDLING OF THE PRODUCT (PRODUCT MISUSE) AT THE REPORTING FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED A PROCEDURE WAS COMPLETED WITH THE USE OF AN EXPIRED PRODUCT. IT IS BELIEVED THE PRODUCT IS STILL IMPLANTED. THE HOSPITAL STAFF INITIALLY RESPONDED THE LOT NUMBER REPORTED WAS USED FOR A CASE THAT OCCURRED IN (B)(6) 2016. THIS INFORMATION DID NOT MATCH THE INFORMATION CONTAINED IN THE CHARGE SHEET THAT INTEGRA HAD. THE HOSPITAL MATERIALS MANAGER LOOKED UP THE CASE THEY HAD FOR THE EXPIRED PRODUCT, AND NO LOT NUMBER WAS RECORDED IN THEIR RECORDS. SHE STATED SHE WILL HAVE TO GO BACK TO THE PATIENT IMPLANT RECORD TO VERIFY THE EVENT (PATIENT PROCEDURE DETAILS/DATE AND LOT USED). ANY NEW OR ADDITIONAL INFORMATION RELATED TO THIS EVENT WILL BE REPORTED IN A FOLLOW UP MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614275 NEURAWRAP NERVE PROTECTOR 10MM ID X 4CM LENGTH NEURAWRAP JXI INTEGRA LIFESCIENCES CORPORATION 1150180

    Patients

    Seq Age Sex Outcome Treatment
    1