BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6445601 · Received March 30, 2017

    Report

    Report Number
    3006425876-2017-00109
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Date of Event
    March 21, 2017
    Report Date
    March 22, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER DID RETURN AN UNOPENED KIT (PRODUCT CODE DE-15703-S-AGK, LOT #71F17A0702). THE CUSTOMER ALSO PROVIDED THREE PHOTOS. THE PHOTOS SHOWED A NEEDLE WITH A CLEAR HUB WITH PIECE(S) BROKEN OUT. THE RETURNED KIT WAS OPENED AND THE 18GA INTRODUCER NEEDLE WITH A CLEAR HUB WAS EXAMINED. NO DEFECTS OR ANOMALIES WERE OBSERVED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE NEEDLE BASED ON THE LOT NUMBER OF AN UNOPENED REFERENCE KIT AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE REPORT OF A BROKEN NEEDLE HUB WAS CONFIRMED BY EXAMINATION OF PHOTOS SUPPLIED BY THE CUSTOMER. THE PHOTOS SHOWED NEEDLE HUBS THAT HAD A PIECE BROKEN OUT OF THEM. THE CUSTOMER ALSO RETURNED AN UNOPENED KIT. THE NEEDLE IN THE KIT WAS NOT CRACKED OR BROKEN. A DHR REVIEW WAS PERFORMED BASED ON A POTENTIAL LOT NUMBER AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. FURTHER INVESTIGATION OF THIS ISSUE IS BEING CONDUCTED UNDER CAPA (B)(4). THE FAILURE INVESTIGATION INDICATES THAT THE PROBABLE CAUSE IS DESIGN RELATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE PRODUCT IS NOT SOLD IN THE US. A SIMILAR DEVICE IS SOLD IN THE US. POTENTIAL LOT NUMBERS - 71F17A0702 OR 71F17A0816.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228682 ARROW CVC KIT: 3-LUMEN 7FR X 20CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR