BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC KIT: 3-LUMEN 7FR X 20CM

    MDR report key: 7297074 · Received February 26, 2018

    Report

    Report Number
    3006425876-2018-00135
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 14, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS NOT SOLD IN THE US. THE 510K # PROVIDED IS FOR A SIMILAR PRODUCT THAT IS SOLD IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED VARIOUS COMPONENTS FROM A DE-15703S-AGK IN A BAG FOR EVALUATION (THE PRODUCT LID STOCK WAS NOT RETURNED). AN INTRODUCER NEEDLE WITH A CRACKED HUB WAS AMONG THE COMPONENTS RETURNED. VISUAL INSPECTION REVEALED THE NEEDLE HUB CONTAINED MANY CRACKS AROUND THE ENTIRE CIRCUMFERENCE OF THE HUB. MICROSCOPIC EXAMINATION REVEALED A SMALL PORTION OF THE HUB HAD SEPARATED FROM THE BODY AND WAS NOT RETURNED. THE RETURNED INTRODUCER NEEDLE WAS ATTACHED TO A LAB INVENTORY SYRINGE FILLED WITH WATER. WHEN THE SYRINGE PLUNGER WAS DEPRESSED, WATER EXITED BOTH THE CRACKS IN THE NEEDLE HUB AS WELL AS THE DISTAL END OF THE NEEDLE. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; HOWEVER, SEVERAL POTENTIAL LOT NUMBERS WERE DETERMINED FROM A SALES HISTORY REVIEW FOR THIS CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE INTRODUCER NEEDLE FROM THE MOST LIKELY POTENTIAL LOT AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. THE REPORTED COMPLAINT OF A DAMAGED NEEDLE HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION. THE RETURNED INTRODUCER NEEDLE HUB CONTAINED MULTIPLE CRACKS AND LEAKED DURING FUNCTIONAL TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. FURTHER INVESTIGATION OF THIS ISSUE IS BEING CONDUCTED UNDER A CAPA. THE CAPA FAILURE INVESTIGATION INDICATES THAT THE PROBABLE CAUSE IS DESIGN RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT DURING THE PUNCTURE OF THE INTRODUCER NEEDLE, THE NEEDLE HUB BROKE. A NEW CVC WAS PLACED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT DURING THE PUNCTURE OF THE INTRODUCER NEEDLE, THE NEEDLE HUB BROKE. A NEW CVC WAS PLACED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139977 ARROW CVC KIT: 3-LUMEN 7FR X 20CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1