BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4508294 · Received February 11, 2015

    Report

    Report Number
    1416980-2015-05246
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Date of Event
    January 15, 2015
    Report Date
    January 15, 2015
    Manufacturer
    SEE H10
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE ACTUAL DEVICE WAS NOT AVAILABLE AS THE CUSTOMER DISCARDED IT DUE TO CYTOSTATIC CONTAMINATION; HOWEVER, A RETENTION SAMPLE EVALUATED. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. GRAVITY AND LEAK TESTING WERE PERFORMED WITHOUT NOTING ANY ISSUES. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CHEMO-AIDE DISPENSING PIN WITH CLEARLINK LUER LEAKED GEMCITIABINE AT THE "FILTER". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102664 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA SEE H10 14I21T742

    Patients

    Seq Age Sex Outcome Treatment
    1