BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA CATHETER

    MDR report key: 1680278 · Received May 12, 2010

    Report

    Report Number
    2134265-2010-02150
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    April 20, 2010
    Report Date
    April 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RECEIVED ONE FLEXIMA VSCL REG 14FR/35CM DEVICE WITH ALL COMPONENTS IN ORIGINAL UNOPENED POUCH WITH PRODUCT LABEL TOGETHER. THE PRODUCT POUCH WAS NOT OPENED INDICATING THE DEVICE WAS NOT USED. A VISUAL EVALUATION FOUND A TEAR IN THE MYLAR SIDE (CLEAR/ TRANSPARENT) OF THE POUCH NEAR THE PRODUCT LABEL AND A SMALL PIECE OF TAPE WAS ATTACHED TO THE TEAR LIKELY BY THE CUSTOMER. EVALUATING THE TEAR, IT APPEARS TO BE CAUSED DURING DISTRIBUTION/ TRANSIT HANDLING, BREACHING THE STERILITY BARRIER. NO DAMAGE WAS OBSERVED ON THE CATHETER DEVICE BUT THE METAL CANNULA WITH TROCAR WAS FOUND TO BE BENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING DAMAGE TO THE PACKAGING WAS NOTED. THE FLEXIMA VSCL REG 14FR/35CM CATHETER HAD A HOLE IN THE STERILE PACKAGING. THERE WAS NO OTHER DAMAGE TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING DAMAGE TO THE PACKAGING WAS NOTED. THE FLEXIMA VSCL REG 14FR/35CM CATHETER HAD A HOLE IN THE STERILE PACKAGING. THERE WAS NO OTHER DAMAGE TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA CATHETER TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - SPENCER M001273040 12968153

    Patients

    Seq Age Sex Outcome Treatment
    1