BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

    MDR report key: 1051405 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00025
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    May 25, 2006
    Report Date
    May 25, 2006
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT: ROOT CAUSE IDENTIFIED: NO SPECIFIC ROOT CAUSE WAS IDENTIFIED, GIVEN THAT NO SAMPLE WAS RECEIVED. CONCLUSIONS: DEVICE HISTORY RECORD WAS REVIEWED AND DOES NOT SHOW EVIDENCE OF ANY ABNORMAL CONDITIONS WITHIN THE MFG PROCESS. CORRECTIVE ACTIONS: NO CORRECTIVE ACTIONS WERE ASSIGNED; ONCE A SAMPLE IS RECEIVED, A FORMAL FAILURE INVESTIGATION WILL BE CARRIED OUT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT THEY ARE EXPERIENCING MULTIPLE PROBLEMS WITH THIS SYRINGE. CONNECTOR TUBING KEEPS BLOWING OFF TIP, OR DOES NOT CONNECT CORRECTLY. THEY NOTICE THAT THERE IS CONTRAST AROUND THE THREADS AFTER AN INJECTION, LIKE A LEAK IN THE CONNECTION. THEY EXPERIENCE ON A DAILY BASIS AT LEAST 50% OF THE LUER LOCK NUTS WILL STRIP AND THEY CAN NOT DISCONNECT THE INJECTOR CONNECTOR TUBING. THEY USE A BOSTON SCIENTIFIC CONNECTOR TUBING, PART NUMBER UNK. INJECTION RATES ARE 13ML RATE FOR A VOLUME OF 34ML TO 39ML, WITH A 1000 PSI LIMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML (LINDEN LUER) DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900103 5290021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK