BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABVISER® AUTOVALVE® IAP MONITORING DEVICE

    MDR report key: 5134947 · Received October 8, 2015

    Report

    Report Number
    1049092-2015-00584
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 15, 2015
    Manufacturer
    CONVATEC, INC.
    Product Code
    FEN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(6) 2015 (B)(6)

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED. NO UNIT WAS RETURNED, SO NO PHYSICAL ANALYSIS COULD BE PERFORMED. THIRD PARTY EXAMINED THE HISTORICAL BATCH RECORDS FOR THE ABV321 MANUFACTURED FROM 05 JANUARY 2015 TO 11 JUNE 2015, INCLUDING LOT NUMBER 150616 WHICH SHOWED THAT ALL SAMPLES TESTED MET THE SPECIFICATION. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER THE DETAILED BATCH REVIEW, NO DISCREPANCIES (INCLUDING NON-CONFORMANCES/DEVIATIONS) WERE FOUND. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED, AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED URINE DID NOT DRAIN THROUGH THE DRAINAGE TUBING OF THE INTRA-ABDOMINAL PRESSURE MONITORING DEVICE. THE ISSUE WAS NOTED IMMEDIATELY UPON CONNECTION. THE DEVICE WAS DISCONNECTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667353 ABVISER® AUTOVALVE® IAP MONITORING DEVICE DEVICE, CYSTOMETRIC, HYDRAULIC FEN CONVATEC, INC. ABV321 150616

    Patients

    Seq Age Sex Outcome Treatment
    1