BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED SPIKE ADAPTER

    MDR report key: 1792105 · Received August 10, 2010

    Report

    Report Number
    6000001-2010-02458
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 22, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    NEP
    PMA / PMN Number
    E643647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE ACTUAL SAMPLE AND ONE UNUSED COMPANION SAMPLE FOR EVALUATION. BOTH SAMPLES WERE VISUALLY AND FUNCTIONALLY INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED ON THE ACTUAL SAMPLE AND NOT CONFIRMED ON THE UNUSED SAMPLE. A CRACK WAS OBSERVED ON THE ACTUAL SAMPLE AND IT FAILED THE UNDER WATER PRESSURE TEST AT 8PSI. HOWEVER, AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    NO DEVIATIONS WERE FOUND IN THE BATCH REVIEW. THE SAMPLE IS AVAILABLE FOR EVALUATION. UPON RECEIPT AND COMPLETION OF THE EVALUATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED TO PROVIDE THE RESULTS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CRACK IN THE VENTED SPIKE ADAPTER. THIS REPORT INVOLVED A (B)(6)PATIENT THAT WAS HAVING ISSUES WITH PAIN ALL DAY SINCE HER EPIDURAL WAS PLACED. THE NURSE DISCOVERED AN EPIDURAL PUMP READING LOW VOLUME, BUT THE MEDICATION HAD NOT DECREASED FROM THE BOTTLE. UPON FURTHER INVESTIGATION, THE NURSE DISCOVERED A CRACK IN THE VENTED SPIKE ADAPTER AND IT WAS NOT PULLING ROPIVACAINE FROM THE BOTTLE. THE PATIENT NEEDED THE EPIDURAL RE-BOLUSED TWICE AND HAD MILD IMPROVEMENT. THE PATIENT HAD INADEQUATE PAIN MANAGEMENT FOR 16 HOURS. THIS INCIDENT OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE. THIS REPORT IS FOR THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED SPIKE ADAPTER SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE R09K02039

    Patients

    Seq Age Sex Outcome Treatment
    1