BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CS-27702-E

    MDR report key: 6807114 · Received August 21, 2017

    Report

    Report Number
    3006425876-2017-00331
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    May 1, 2017
    Report Date
    August 11, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER CORRECTED TO ARROW INTERNATIONAL INC., READING, PA. THE CUSTOMER RETURNED ONE OPENED CS-24301-E KIT FOR EVALUATION. THE ARS SYRINGE AND INTRODUCER NEEDLE WERE INSPECTED AND NO ISSUES WERE OBSERVED. THE SYRINGE WAS TESTED PER INSPECTION PROCEDURE BY OCCLUDING THE TIP, PULLING THE PLUNGER BACK, AND RELEASING THE PLUNGER. THE PLUNGER DID NOT RETURN TO ITS ORIGINAL POSITION, INDICATING THERE IS AN ISSUE WITH THE SEAL. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE CUSTOMER REPORTED ISSUE OF THE ARS SYRINGE LEAKING WAS CONFIRMED DURING THE SAMPLE INVESTIGATION. FUNCTIONAL TESTING WAS PERFORMED ON THE SYRINGE AND THE SEAL WAS DETERMINED TO BE FAULTY. A DHR REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE PROBABLE CAUSE OF THIS ISSUE IS MANUFACTURING RELATED AND A NON-CONFORMANCE REQUEST HAS BEEN GENERATED TO FURTHER INVESTIGATE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE DOCTOR FOUND THE BLUE SYRINGE LEAKING DURING USE. ANOTHER DEVICE WAS USED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE DOCTOR FOUND THE BLUE SYRINGE LEAKING DURING USE. ANOTHER DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588924 ARROW CS-27702-E CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F17B1167

    Patients

    Seq Age Sex Outcome Treatment
    1