BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO GEMSTAR SPLT YLLW STRIPE 110IN

    MDR report key: 3822992 · Received February 19, 2014

    Report

    Report Number
    9615050-2014-01296
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE CONSISTING OF SET A AND SET B WAS RECEIVED AND EVALUATED. TESTING FOUND A CUT IN THE TUBING PROXIMAL TO THE SECURE LOCK MALE ADAPTER OF SET B. THE CUT IS HALFWAY THROUGH THE TUBING. THE PROBABLE CAUSE OF THE CUT COULD HAVE BEEN DUE TO THE TUBING CUTTER MACHINE DURING MANUFACTURING. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A CRACK IN THE TUBING; SUBSEQUENTLY, A LEAK WAS NOTED. THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT AN UNSPECIFIED CONNECTION OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. DURING VISUAL EXAMINATION OF THE TUBING SET AT THE USER FACILITY, A CRACK AND A SPLIT WERE NOTED. NO INFO WAS PROVIDED IF THE LEAK OCCURRED DURING OR PRIOR TO PT USE; HOWEVER, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104045 MICRO GEMSTAR SPLT YLLW STRIPE 110IN 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK