BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC SAF PUMP

    MDR report key: 1943672 · Received December 15, 2010

    Report

    Report Number
    2026095-2010-00304
    Event Type
    Other
    Date Received
    December 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PT HAD FIRST PUMP INFUSE IN 30 HOURS INSTEAD OF 50 HOURS. HE RECEIVED A SECOND PUMP WHICH INFUSED IN 24 HOURS INSTEAD OF 50 HOURS. SELECT-A-FLOW (SAF) WAS CONFIRMED SECURE AND THE FILL VOLUME WAS CONFIRMED BY THE PHARMACY TO BE 400ML. NO ADVERSE EVENT REPORTED. DATE OF EVENT: UNK. ANP: ASK BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC SAF PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. CB004 ANP

    Patients

    Seq Age Sex Outcome Treatment
    1