BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL ENTRY NEEDLE (BX)

    MDR report key: 4243677 · Received November 11, 2014

    Report

    Report Number
    2134265-2014-06852
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    August 13, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FMI
    PMA / PMN Number
    K840033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE NEEDLE WAS BROKEN IN TWO {2} PIECES. THE PROTECTIVE SHEATH WAS BENT AT THE POINT WHERE THE NEEDLE WAS BROKE IN TWO {2} PIECES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20OCT2014. IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE, THE ARTERIAL ENTRY NEEDLE (EN) -18 WAS FOUND BENT WHEN IT REMOVED FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE NEEDLE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727220 ARTERIAL ENTRY NEEDLE (BX) NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BOSTON SCIENTIFIC - MAPLE GROVE M001441691 0004725023

    Patients

    Seq Age Sex Outcome Treatment
    1