BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL MICRO EXT SET W/CL INJ SITE60IN 1.5M LL 0.5ML STERILE NON

    MDR report key: 2021337 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01918
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 03/22/2011. ONE FLO-LINK VALVE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE REVEALED THE MALE END OF A LUER FROM ANOTHER SET WAS BROKEN INSIDE OF THE FLO-LINK VALVE. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE OF THIS CONDITION WAS ATTRIBUTED TO THE USE OF A KELLY CLAMP TO REMOVE THE DEVICE FROM THE CONNECTOR. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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

    THE CUSTOMER REPORTED TO BAXTER (B)(4) AN UNKNOWN QUANTITY OF CLEARLINK MICROBORE EXTENSION SETS THAT ARE CRACKING/BREAKING. ACCORDING TO THE REPORT, THE MALE END OF EXTENSION TUBING BROKE OFF INSIDE OF A FLO-LINK VALVE WHEN TRYING TO DISCONNECT. THE CONDITION OCCURRED DURING PATIENT USE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL MICRO EXT SET W/CL INJ SITE60IN 1.5M LL 0.5ML STERILE NON SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 FLOLINK IV ACCESS DEVICE