BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIVOLUME CATHETER EXTENSIONSET

    MDR report key: 1905181 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05150
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER SENT IN AN ACTUAL AND A COMPANION SAMPLE FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE ACTUAL SAMPLE WAS CONTAMINATED WITH BLOOD AND THE MICROBORE TUBE WAS DISCONNECTED FROM THE FEMALE LUER LOCK ADAPTOR. THEREFORE THE REPORTED CONDITION WAS CONFIRMED. MEANWHILE, THE REPORTED CONDITION WAS NOT CONFIRMED FOR THE COMPANION SAMPLE THAT WAS RETURNED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. A TREND REVIEW WAS PERFORMED AND THERE WERE NO OTHER SIMILAR COMPLAINTS THAT WERE REPORTED IN THE PAST TWELVE MONTHS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 4 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FOR BAXTER (B)(4) A MINIVOLUME CATHETER EXTENSION SET THAT BROKE OFF ON ATTACHMENT TO THE DRIP SET. THE EVENT OCCURRED DURING PATIENT USE. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIVOLUME CATHETER EXTENSIONSET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10B03V522

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION