BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUJECT VARIABLE INJECTION NEEDLE

    MDR report key: 1120463 · Received August 14, 2008

    Report

    Report Number
    1037905-2008-00104
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 16, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    GAA
    PMA / PMN Number
    K941305/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR EVAL OF THE RETURNED INJECTION NEEDLE CONFIRMED THE REPORT OF NEEDLE PENETRATION OF THE OUTER CATHETER. A SMALL HOLE WAS DETECTED WHERE THE NEEDLE HAS PENETRATED THE OUTER CATHETER. THE SMALL HOLE IS LOCATED IN THE BLACK SECTION OF THE CATHETER NEAR THE DISTAL END. THE INJECTION NEEDLE HANDLE WAS RETURNED IN THE FULLY ADVANCED POSITION; THE HANDLE POSITION CORRESPONDS TO FULL NEEDLE EXTENSION. DURING OUR LABORATORY ANALYSIS, THE HANDLE WAS RETRACTED AND THE NEEDLE WAS VISUALIZED INSIDE THE DISTAL END OF THE OUTER CATHETER. THE CATHETER WAS PLACED IN A STRAIGHT POSITION. WHEN THE HANDLE IS MANIPULATED, THE NEEDLE EXTENDED AND RETRACTS PROPERLY. TWO KINKS IN THE OUTER CATHETER WERE NOTED APPROX 65CM AND 75CM FROM THE HANDLE. THERE IS ALSO A KINK APPROX 5CM FROM THE HANDLE. THE OUTER CATHETER WAS MEASURED AND FOUND TO BE WITHIN THE APPROPRIATE SPECIFICATION. A PRODUCT DISCREPANCY THAT COULD HAVE CONTRIBUTED TO NEEDLE PENETRATION OF THE OUTER SHEATH WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. AFTER A REVIEW OF THE DEVICE HISTORY FOR THIS LOT NUMBER, WE CAN REPORT THAT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE DEVICES WERE PREVIOUSLY DISTRIBUTED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS PERCENTAGE, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE CAN NOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE. WHILE CLINICAL CONDITIONS ARE NOT THE SOLE DETERMINING FACTORS, THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE THE CAUSE FOR THIS OBSERVATION. HOWEVER, WE CAN PROVIDE THE FOLLOWING COMMENTS: THE INFO PROVIDED INDICATED THE ENDOSCOPE WAS PLACED IN A FLEXED POSITION DURING USE. 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. KINKS IN THE CATHETER CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE DURING USE AND/OR GENERAL HANDLING. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE ADVISE THE USER TO ADVANCE THE DEVICE THROUGH THE ACCESSORY CHANNEL IN SHORT INCREMENTS. THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. PRIOR TO DISTRIBUTION, ALL ACUJECT VARIABLE INJECTION NEEDLE ARE SUBJECTED TO A FUNCTIONAL TEST TO ENSURE APPROPRIATE NEEDLE EXTENSION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTIONS: THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. NO FURTHER ACTION IS WARRANTED BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ENDOSCOPY ACUJECT VARIABLE INJECTION NEEDLE. THE DEVICE WAS ADVANCED THROUGH THE ENDOSCOPE. WHEN ATTEMPTING TO EXTEND THE NEEDLE FROM THE OUTER SHEATH, THE NEEDLE PENETRATED THE OUTER SHEATH. THE INJECTION NEEDLE WAS WITHDRAWN AND ANOTHER NEEDLE WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUJECT VARIABLE INJECTION NEEDLE GAA, NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA COOK ENDOSCOPY W2484789

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK