BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML BX50

    MDR report key: 1051397 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00008
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    November 6, 2007
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG REPORT. HISTORY RECORD: MODEL # 900101 LOT NUMBER: 708210 (THIS LOT NUMBER IS INCORRECT, LOT NUMBERS ARE SEVEN DIGITS) ACCORDING TO OUR RECORDS IT COULD BE 7082100 OR 7082101. FOR LOT NUMBER 7082100: QTY PRODUCED: 192 BX; DATE OF MFG: 03/23/2007; QC QUANTITY INSPECTED: 300 UNITS; NCR GENERATED: NO NCR GENERATED. FOR LOT NUMBER 7082101: QTY PRODUCED: 192 BX; DATE OF MFG: 03/22/2007; QC QUANTITY INSPECTED: 300 UNITS; NCR GENERATED: ONE NCR GENERATED FOR A DIFFERENT ISSUE. ROOT CAUSE IDENTIFIED: NO. DEFECT COULD NOT BE CONFIRMED. CONCLUSIONS: DEFECT WAS NOT CONFIRMED SINCE NO SAMPLE WAS RECEIVED. LOT NUMBER PROVIDED BY THE CUSTOMER WAS NOT CORRECT, LOT NUMBERS MUST BE OF SEVEN DIGITS. POSSIBLE LOT NUMBERS WERE REVIEWED WITHOUT NON CONFORMANCES RELATED TO THIS DEFECTIVE GENERATED DURING THE MFG OF THESE LOT NUMBERS. AS PROCESS THERE IS PRESSURE APPLIED TO SAMPLES OF EACH LOT NUMBER, THE PRESSURE APPLIED IS 1300 PSI WHICH IS GREATER THAN THE PRESSURE USED (75-1200 PSI) BY THE CUSTOMER. THIS TEST IS PERFORMED ACCORDING TO INSTRUCTION NUMBER. CORRECTIVE ACTIONS: CAPA: DURING PREVIOUS INVESTIGATIONS IT WAS FOUND THAT THE SYRINGE TIP THREAD NEEDS TO BE REFURBISH AS WELL ON THE LOCKNUT THREAD, BUT THESE ACTIONS WILL BE CONSIDERED AS QUALITY IMPROVEMENTS SINCE THE DEFECT REPORTED WAS NOT CONFIRMED. SYRINGE TIP THREAD IMPROVEMENT. LOCKNUT THREAD IMPROVEMENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THEY HAD 4 LUER LOCK NUTS COME OFF THE 900101 SYRINGE WHILE DOING AN AORTIC ARCH SHOT USING A PROTOCOL OF 20ML/SEC THROUGH A 5 FRENCH CATHETER WITH AN UNK PSI. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML BX50 DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900101 708210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK