BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 16 GA X 8" (20 CM)

    MDR report key: 6807078 · Received August 21, 2017

    Report

    Report Number
    3006425876-2017-00332
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    June 1, 2017
    Report Date
    August 11, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER CORRECTED TO ARROW INTERNATIONAL INC., READING, PA. THE CUSTOMER RETURNED ONE OPENED CS-24301-E KIT. THE ARS SYRINGE AND INTRODUCER NEEDLE WERE EXAMINED AND NO ISSUES WERE OBSERVED. THE SYRINGE WAS VACUUM TESTED PER INSPECTION PROCEDURE BY OCCLUDING THE TIP, PULLING THE PLUNGER BACK, AND RELEASING THE PLUNGER. THE PLUNGER RETURNED TO ITS ORIGINAL POSITION. THE PLUNGER WAS ROTATED 45 DEGREES CLOCKWISE AND THE TEST WAS REPEATED. NO ISSUES WERE OBSERVED. THE SYRINGE WAS PUSH TESTED PER INSPECTION PROCEDURE BY PULLING THE PLUNGER BACK, OCCLUDING THE TIP, AND PUSHING THE PLUNGER DOWN. RESISTANCE WAS FELT AND THE PLUNGER DID NOT TOUCH THE BOTTOM OF THE BARREL. NO ISSUES OBSERVED. THE INTRODUCER NEEDLE WAS ATTACHED TO THE ARS SYRINGE AND USED TO DRAW WATER. NO ISSUES WERE OBSERVED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. OTHER REMARKS: THE CUSTOMER REPORTED ISSUE OF THE ARS SYRINGE LEAKING IN USE WAS NOT CONFIRMED DURING THE SAMPLE INVESTIGATION. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED ARS SYRINGE AND INTRODUCER NEEDLE AND NO ISSUES WERE OBSERVED. A DHR REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. AS NO PROBLEM WAS FOUND WITH THE RETURNED SAMPLE NO ADDITIONAL ACTION SHALL BE TAKEN AT THIS TIME.

    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
    588086 ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL INC. 71F17B1668

    Patients

    Seq Age Sex Outcome Treatment
    1