BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUJECT INJECTION NEEDLE

    MDR report key: 1652983 · Received March 30, 2010

    Report

    Report Number
    1037905-2010-00143
    Event Type
    Malfunction
    Date Received
    March 30, 2010
    Date of Event
    March 1, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FBK
    PMA / PMN Number
    K941305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVALUATION. WE COULD NOT CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER COULD NOT 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 REPORT IS RARE. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. NEEDLE EXTENSION DIFFICULTY 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 ACUJECT VARIABLE INJECTION NEEDLES ARE SUBJECTED TO A FUNCTIONAL TEST TO ENSURE APPROPRIATE NEEDLE EXTENSION. 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 ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK ENDOSCOPY ACUJECT VARIABLE INJECTION NEEDLE. DURING THE PROCEDURE, THE NEEDLE WOULD NOT EXTEND FROM THE OUTER CATHETER. ANOTHER MFR'S DEVICE 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 INJECTION NEEDLE FBK, ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK COOK ENDOSCOPY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIF-160 ENDOSCOPE