BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 16 GA X 12" (30 CM)

    MDR report key: 6349954 · Received February 22, 2017

    Report

    Report Number
    9680794-2017-00030
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    February 2, 2017
    Report Date
    February 6, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). A 16GA X 12" SINGLE LUMEN CATHETER (K-04400-001A) WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CATHETER SHOWED EVIDENCE OF USE. THE CATHETER BOX CLAMP WAS STILL ATTACHED TO THE CATHETER BODY WITH SUTURE THREADS ATTACHED TO THE BOX CLAMP SUTURE WINGS. MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLE REVEALED A CRACK ALONG EACH OF THE LUER HUB SUTURE WINGS. THE CRACKS WERE BOTH ALONG THE BASE OF THE SUTURE WINGS WHERE THE WINGS CONNECT TO THE LUER HUB BODY. BOTH OF THE CRACKS WERE JAGGED IN APPEARANCE AND BECAME MORE EVIDENT WHEN THE LUER HUB WAS PULLED AWAY FROM THE SUTURE WINGS. THE CATHETER BODY APPEARED TO BE NORMAL WITH NO OBVIOUS DEFECTS. WITH THE CATHETER BODY OCCLUDED, WATER WAS INJECTED INTO THE CATHETER LUER HUB USING A LAB INVENTORY 10 ML SYRINGE. A LEAK WAS OBSERVED FROM THE JUNCTURE HUB WHEN THE CATHETER WAS PRESSURIZED. THE LOCATION OF THE LEAK WAS CONSISTENT WITH THE CRACKS IDENTIFIED DURING THE VISUAL INSPECTION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE PRODUCT INSTRUCTIONS FOR USE (IFU), S-04400-117A, CAUTIONS THAT ALCOHOL AND ACETONE CAN WEAKEN THE STRUCTURE OF POLYURETHANE MATERIALS. INFORMATION REGARDING CHEMICAL CONTACT WAS NOT PROVIDED BY THE CUSTOMER. (CON'T) OTHER REMARKS: THE REPORTED COMPLAINT FOR A CATHETER LEAKING IN USE WAS CONFIRMED THROUGH FUNCTIONAL AND VISUAL INSPECTION OF THE RETURNED COMPLAINT SAMPLE. MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLE REVEALED CRACKS ALONG EACH OF THE LUER HUB SUTURE WINGS. THE CRACKS WERE BOTH ALONG THE BASE OF THE SUTURE WINGS WHERE THE WINGS CONNECT TO THE LUER HUB BODY. A FUNCTIONAL LEAK TEST CONFIRMED THE CATHETER LEAKED AT THIS LOCATION. BASED ON THE LOCATION AND JAGGED APPEARANCE OF THE CRACKS, IT WAS DETERMINED THAT THE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT DURING USE, THE INJECTION HUB WAS CRACKED AND LEAKAGE WAS CONFIRMED. A NEW DEVICE WAS USED. NO DELAY OR INTERRUPTION IN THERAPY. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT DURING USE, THE INJECTION HUB WAS CRACKED AND LEAKAGE WAS CONFIRMED. A NEW DEVICE WAS USED. NO DELAY OR INTERRUPTION IN THERAPY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133683 ARROW CVC SET: 16 GA X 12" (30 CM) SYRINGE, PISTON FOZ ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1