BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADUJECT VARIABLE INJECTION NEEDLE

    MDR report key: 1661979 · Received April 8, 2010

    Report

    Report Number
    1037905-2010-00171
    Event Type
    Malfunction
    Date Received
    April 8, 2010
    Date of Event
    March 8, 2010
    Report Date
    March 9, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FBK
    PMA / PMN Number
    K941305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE INJECTION NEEDLE HANDLE WAS RETURNED IN THE FULLY ADVANCED POSITION. THIS HANDLE POSITION CORRESPONDS TO FULL NEEDLE EXTENSION. DURING OUR LABORATORY ANALYSIS, THE HANDLE WAS PULLED BACK TO FULLY RETRACT THE NEEDLE. THE CATHETER OF THE INJECTION NEEDLE DEVICE WAS PLACED IN A STRAIGHT POSITION. WHEN THE HANDLE IS ADVANCED AND PULLED BACK TO MOVE THE NEEDLE IN AND OUT OF THE OUTER CATHETER, THE NEEDLE EXTENDED AND RETRACTS PROPERLY. OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT OF THE NEEDLE PUNCTURE BY THE CATHETER. THE NEEDLE HAS STARTED TO PENETRATE THE INNER WALL OF THE OUTER CATHETER FROM THE INSIDE. DURING OUR LABORATORY ANALYSIS, THE OUTER CATHETER WAS CUT OPEN AND VISUALLY EXAMINED UNDER MAGNIFICATION. A SMALL DAMAGED AREA IN THE OUTER CATHETER WHERE THE NEEDLE BEGAN TO PENETRATE THE INNER WALL WAS DETECTED. THE SMALL DAMAGED AREA IS LOCATED NEAR THE BLACK SECTION OF THE OUTER CATHETER AT THE DISTAL END OF THE DEVICE. A PRODUCT DISCREPANCY THAT COULD HAVE CONTRIBUTED TO NEEDLE PENETRATION OF THE OUTER CATHETER WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: NEEDLE PENETRATION OF THE OUTER CATHETER CAN OCCUR IF NEEDLE EXTENSION IS ATTEMPTED WITH THE CATHETER IN A COILED OR CURVED POSITION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO UNCOIL THE CATHETER AND STRAIGHTEN COMPLETELY. THE INSTRUCTIONS FOR USE ALSO CAUTION THE USER THAT EXTENDING THE NEEDLE WHILE THE CATHETER IS COILED MAY RESULT IN DAMAGE TO THE PERFORMANCE CHARACTERISTICS OF THE DEVICE. PRIOR TO DISTRIBUTION, ALL ACUJET VARIABLE INJECTION NEEDLES ARE SUBJECTED TO A FUNCTIONAL TEST TO ENSURE APPROPRIATE NEEDLE EXTENSION FROM THE OUTER CATHETER. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTIONS: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK ENDOSCOPY ACUJECT VARIABLE INJECTION NEEDLE IN AN ATTEMPT TO INJECT A GASTRIC NODULE. AS THE NEEDLE WAS ADVANCED, THE NEEDLE PENETRATED THE SIDE WALL OF THE OUTER CATHETER (INSTEAD OF EXITING THE DISTAL END OF THE OUTER CATHETER). THE NEEDLE WAS RETRACTED AND THE INJECTION NEEDLE DEVICE WAS REMOVED FROM THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEEDLE. NO HARM TO THE PATIENT OCCURRED. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADUJECT VARIABLE INJECTION NEEDLE ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK COOK ENDOSCOPY W2740011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN OLYMPUS ENDOSCOPE (UNK MODEL NUMBER)