BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUJECT VARIABLE INJECTION NEEDLE

    MDR report key: 1627112 · Received March 4, 2010

    Report

    Report Number
    1037905-2010-00099
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Report Date
    February 3, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FBK
    PMA / PMN Number
    K941305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR EVAL OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE NEEDLE HAS PENETRATED THE INNER WALL OF THE OUTER CATHETER, CAUSING NEEDLE EXTENSION DIFFICULTIES. A SMALL DAMAGED AREA IN THE OUTER CATHETER WHERE THE NEEDLE PENETRATION OCCURRED WAS DETECTED THROUGH A VISUAL EXAMINATION. THE SMALL DAMAGED AREA IS LOCATED IN THE BLACK SECTION OF THE OUTER CATHETER NEAR THE DISTAL END. A DISCREPANCY OR ANOMALY SPECIFIC TO THE PRODUCT THAT COULD HAVE CAUSED THIS OCCURRENCE 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. CONCLUSION: 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 ACCUJECT VARIABLE INJECTION NEEDLES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE APPROPRIATE NEEDLE EXTENSION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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 ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY ACCUJECT VARIABLE INJECTION NEEDLE. THE INJECTOR WAS ADVANCED THROUGH THE ENDOSCOPE AND INTO POSITION. INSTEAD OF EXTENDING FROM THE DISTAL END OF THE OUTER CATHETER, THE NEEDLE EXITED THE SIDE OF THE OUTER CATHETER. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE AND ANOTHER INJECTION NEEDLE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL MEDICAL PROCEDURES DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUJECT VARIABLE INJECTION NEEDLE FBK, ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK COOK ENDOSCOPY W2756054

    Patients

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