BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CATH SET:20 GA CATH/22 GA NDL

    MDR report key: 5274145 · Received December 8, 2015

    Report

    Report Number
    9680794-2015-00143
    Event Type
    Malfunction
    Date Received
    December 8, 2015
    Date of Event
    November 18, 2015
    Report Date
    November 19, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). DEVICE EVALUATION: THE REPORTED COMPLAINT WAS CONFIRMED THROUGH EXAMINATION OF A RETURNED PRODUCT SAMPLE. THE CUSTOMER PROVIDE A SIN GLE-LUMEN CATHETER THAT WAS KINKED ALONG THE BODY AT 1, 8.5 AND 10 CM FROM THE JUNCTURE HUB. USING A 10 ML SYRINGE, WATER WAS INJECTED INTO THE CATHETER AND A LEAK WAS OBSERVED FROM THE KINK LOCATED ADJACENT TO THE SLEEVE AT THE JUNCTURE HUB. MICROSCOPIC EXAMINATION REVEALED A CRACK IN THE CATHETER BODY. THE PROVIDED INSTRUCTIONS WARN THAT CARE SHOULD BE EXERCISED SO THAT THE INDWELLING CATHETER IS NOT INADVERTENTLY KINKED AT THE HUB AREA SINCE KINKING MAY WEAKEN THE CATHETER WALL. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON SALES HISTORY AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. SINCE IT APPEARS THAT THE CRACK RESULTED FROM AN INADVERTENT KINK IN THE CATHETER BODY, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, SOLUTION LEAKAGE WAS CONFIRMED SO THE CATHETER WAS REMOVED. AFTER THE CATHETER WAS REMOVED, THE USER FOUND A CRACK AT THE TIP. AS A RESULT, A NEW KIT WAS OPENED AND THE CATHETER WAS PLACED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT. NO DEATH OR COMPLICATIONS OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804959 ARTERIAL CATH SET:20 GA CATH/22 GA NDL ARTERIAL CATHETER PRODUCTS DQX ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1