BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS TRAY 6FR X 16CM

    MDR report key: 5074730 · Received September 14, 2015

    Report

    Report Number
    1625685-2015-00200
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 17, 2015
    Report Date
    November 18, 2015
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). - UPON CAREFUSION INVESTIGATION, A FOLLOW UP EMDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. CONSEQUENTLY, THE QUALITY OF THE PRODUCT COULD NOT BE EVALUATED IN REGARDS TO THE REPORTED FAILURE MODE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR LOT 0000795318. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO A ROOT CAUSE FOR THE REPORTED FAILURE MODE. TRENDING DATA WAS CAPTURED FROM NOVEMBER 2013 TO OCTOBER 2015. AN ADVERSE TREND WAS NOT DETECTED. BASED ON THE INVESTIGATION, DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ISSUES ASSOCIATED WITH THE REPORTED FAILURE. TRENDING INFORMATION ON THE FAILURE MODE DID NOT DETECT A NEGATIVE TREND. UNAVAILABILITY OF THE PRODUCT FOR SAMPLE ANALYSIS PREVENTS FURTHER INVESTIGATION INTO THE REPORTED FAILURE MODE. THEREFORE, A ROOT CAUSE COULD NOT BE ESTABLISHED. A QUALITY NOTIFICATION HAS BEEN ISSUED TO THE SUPPLIER OF THE COMPONENT ASSOCIATED WITH THE REPORTED FAILURE MODE. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    CUSTOMER STATED VIA EMAIL THAT THERE WAS SEVERAL MORE 25G NEEDLE MALFUNCTIONS. THE NEEDLE IS COMING APART FROM THE SAFETY LOCK AND FLUID IS SPRAYING THE CLINICIAN. (B)(6) 2015 ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: THERE WAS 1 DEFECTIVE FOR THIS CASE AND PROCEDURE COMPLETED USING DIFFERENT NEEDLE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605230 SAFE-T-CENTESIS TRAY 6FR X 16CM NEEDLE, CATHETER GCB CAREFUSION PIG1260T 0000795318

    Patients

    Seq Age Sex Outcome Treatment
    1