BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 1547352 · Received November 13, 2009

    Report

    Report Number
    1036844-2009-00292
    Event Type
    Malfunction
    Date Received
    November 13, 2009
    Date of Event
    August 6, 2009
    Report Date
    November 13, 2009
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K820648
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. THE RETURNED DEVICE WAS EVALUATED AND THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE, IT IS REPORTABLE. EVALUATION: ONE INTRODUCER NEEDLE WAS RECEIVED FOR EVALUATION. THE RETURNED NEEDLE WAS BROKEN AND SEPARATED INTO TWO PIECES. THE BREAK OCCURRED IN THE CANNULA SHAFT APPROX 2 CM AWAY FROM THE DISTAL TIP OF THE NEEDLE HUB. IT APPEARS THAT THE NEEDLE WAS SUBJECTED TO EXCESSIVE FORCE ON THE VERTICAL AXIS CAUSING THE CANNULA TO BOW AND THEN BREAK. THE PRODUCT'S INSTRUCTIONS FOR USE (ARROW P/N# K-14703-110B REV 4.0) DESCRIBE SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF NEEDLE DAMAGE DURING USE. PROCEDURE, STEP 5 ADVISES THAT WHEN USING THE 18GA INTRODUCER NEEDLE, THE VESSEL MAY BE PRE-LOCATED WITH A 22GA NEEDLE. THE REPORT OF NEEDLE BROKE WAS CONFIRMED THROUGH VISUAL EXAMINATION OF THE RETURNED SAMPLE. BASED ON THE EVENT DESCRIPTION AND PHYSICAL EVIDENCE, THE POTENTIAL CAUSE OF THIS ISSUE IS PROCEDURE/PT ANATOMY RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE AK-15703 WAS BEING PLACED IN THE EMERGENCY DEPT, AND THE NEEDLE BROKE IN TWO. ADD'L INFO RECEIVED FROM THE SALES REP ON 8/11/09 STATED THE NEEDLE WAS NOT IN THE PT AT THE TIME THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 7 FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL., INC. RF9068372

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK