BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM

    MDR report key: 1932521 · Received December 18, 2010

    Report

    Report Number
    6000001-2010-05952
    Event Type
    Malfunction
    Date Received
    December 18, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE ACTUAL SAMPLE FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED. THE Y-SITE WAS OBSERVED TO BE DEFORMED. THIS DEFECT WAS CREATED WHEN THE Y SITE COMPONENT WAS PROTRUDED OUT OF THE SEALING PERIMETER OF THE POUCH AND GETS PRESSED BY THE HEAT SEAL DIE AT FORM FILL SEAL MACHINE BASED ON THE DAMAGED MARK FOUND ON THE RETURNED SAMPLE. THE HEAT SEAL DIE IS USED TO SEAL THE TOP AND BOTTOM POUCH TOGETHER. THE GUIDE SUPPORT BARS AT THE GUIDING PROCESS FOR ALL FORM FILL SEAL MACHINES WERE EXTENDED TO PREVENT THE SET TO MOVE OUT OF POSITION. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER OF A CRUSHED Y-SITE FOUND ON AN INTERLINK CONTINU-FLO SOLUTION SET. THE CONDITION OCCURRED DURING PRIMING WITH NORMAL SALINE. THE SALINE LEAKED OUT OF THE Y-SITE, AND THE NURSE NOTICED THE Y-SITE WAS CRUSHED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1