BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSUFFLATION NEEDLE -

    MDR report key: 1902603 · Received November 18, 2010

    Report

    Report Number
    3005075853-2010-06590
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FDP
    PMA / PMN Number
    K910875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE CHECKED HIS INSULIN AND HE HAD 21UNITS IN THE RESERVOIR. AN HOUR LATER, HE RECEIVED A NO DELIVERY ALARM DURING BASAL, AND WHEN HE CHECKED HIS STATUS SCREEN, IT WAS 0 UNITS LEFT IN THE RESERVOIR. THE CUSTOMER STATED THAT SIMILAR INCIDENTS HAPPENED TWO TO THREE TIMES IN THE PAST TWO WEEKS. TROUBLESHOOTING WAS PERFORMED. THE ALARM HISTORY REVEALED A MOTOR ERROR ALARM. RAN A DISPLACEMENT TEST AND SELF TEST AND THE DEVICE PASSED THE TESTS. REQUESTED THE CUSTOMER TO REVIEWED THE AMOUNT OF INSULIN IN THE RESERVOIR PRIOR INSERTING IN THE DEVICE. ASKED THE CUSTOMER TO CHECK THE UNITS LEFT ON STATUS SCREEN TO SEE IF THE TOTALS MATCHED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, AIR COULD NOT BE ENTERED AFTER PUNCTURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFFLATION NEEDLE - INSUFFLATION NEEDLE - 120MM LENGTH FDP ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1