BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUJECT VARIABLE INJECTION NEEDLE (DEVICE 1 OF 2)

    MDR report key: 1022722 · Received March 26, 2008

    Report

    Report Number
    1037905-2008-00036
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 26, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    GAA
    PMA / PMN Number
    K941305/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED BECAUSE THE AFFECTED PRODUCT WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVALUATION. WE WERE UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS UNABLE TO BE PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDER HISTORY, THE LOT NUMBER WAS UNABLE TO BE DETERMINED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CONCLUSION: WE WERE UNABLE TO CONDUCT A FULL INVESTIGATION BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION WAS UNABLE TO BE DETERMINED. HOWEVER, WE CAN PROVIDE THE FOLLOWING COMMENTS: 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 ADVANCING THE NEEDLE WHILE THE CATHETER IS COILED MAY RESULT IN DAMAGE TO THE PERFORMANCE CHARACTERISTICS OF THE DEVICE. PRIOR TO DISTRIBUTION, ALL ACUJECT VARIABLE INJECTION NEEDLES ARE SUBJECTED TO A FUNCTIONAL TEST TO ENSURE APPROPRIATE NEEDLE EXTENSION. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. 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 ACUJECT VARIABLE INJECTION NEEDLE (DEVICE 1 OF 2). THE INJECTION NEEDLE WAS ADVANCED INTO POSITION AND THE USER ATTEMPTED TO EXTEND THE NEEDLE FROM THE OUTER CATHETER. INSTEAD OF EXTENDING FROM THE OUTER CATHETER, THE NEEDLE PENETRATED THE SIDE OF THE OUTER CATHETER. THE INJECTION NEEDLE WAS REMOVED AND THE PHYSICIAN USED ANOTHER ACUJECT VARIABLE INJECTION NEEDLE (DEVICE 2 OF 2) WITH THE SAME RESULT. AN ENDOSCOPIC CLIPPING DEVICE WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION. FOR SUSPECT MEDICAL DEVICE INFORMATION ON DEVICE 2, SEE REPORT NUMBER 1037905-2008-00037.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUJECT VARIABLE INJECTION NEEDLE (DEVICE 1 OF 2) GAA NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA COOK ENDOSCOPY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK