BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2950616 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03324
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL DEVICE ANALYSIS WAS COMPLETED. DURING VISUAL AND FUNCTIONAL TESTING, THE DEVICE MET SPECIFICATION. PRESSURE TESTING AS WELL AS A LUER GAUGE TEST WAS ALSO PERFORMED AND THE DEVICE MET SPECIFICATION. THE DEVICE PASSED ALL TESTING AND MET SPECIFICATION; HOWEVER, THE DEVICE DID LEAK WHEN TESTED WITH THE NON-BAXTER DEVICE RETURNED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED UNIT WAS RECEIVED FOR EVALUATION RELATED TO A LEAKS-DISCONNECTION CONDITION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED PROBLEM WAS NOT CONFIRMED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. NO CONCLUSION COULD BE DRAWN FROM THE INVESTIGATION. IF RELEVANT ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER TESTING, THE FEMALE LUER WAS FOUND TO NOT MEET SPECIFICATION FOR THE INSIDE DIAMETER. THEREFORE THE REPORT OF A LEAK WAS CONFIRMED. A CAPA HAS BEEN OPENED IN ORDER TO ADDRESS THIS ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE (1) ONE INTERLINK I.V. CATHETER EXTENSION SET OF WHICH LEAKING WAS DETECTED BETWEEN THE FEMALE HUB OF THE INTERLINK SET AND THE THREADS OF A NON-BAXTER LUER ACTIVATED DEVICE (LAD) INJECTION SITE, WHICH HAD BEEN SWAPPED IN PLACE OF THE INTERLINK INJECTION SITE. THE ISSUE WAS RESOLVED BY REPLACING THE SETUP WITH UNSPECIFIED INTERLINK Y-TYPE TUBING; THE LINE WAS FLUSHED WITH NO FURTHER LEAKAGE NOTED; BLOOD RETURN WAS OBTAINED AND THE PATIENT'S TREATMENT WAS INITIATED WITHOUT FURTHER EVENT. THE EVENT OCCURRED IN THE ADULT ONCOLOGY DAY HOSPITAL. THERE IS PATIENT INVOLVEMENT; HOWEVER, THERE IS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55101 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 10ML NS POSIFLUSH SYRINGE| MICROCLAVE LAD CONNECTOR (B)(4)