BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL LINE KIT

    MDR report key: 1884211 · Received June 11, 2010

    Report

    Report Number
    1036844-2010-00072
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    April 7, 2009
    Report Date
    March 15, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL. ADDITIONAL INFO: NO SAMPLE WAS RETURNED FOR INVESTIGATION, IT WAS REPORTED AS DISCARDED. THE CUSTOMER REPORTED THE ARTERIAL LINE CRACKED AT THE HUB RESULTING IN LEAKING AND EXPOSURE TO AIR; NO SLEEVE WAS PRESENT REINFORCING THE CATHETER AT THE HUB. THE CUSTOMER REPORTED THIS AS A REOCCURRING PROBLEM; HOWEVER, DID NOT PROVIDE A SAMPLE FOR INVESTIGATION. THE INSTRUCTION BOOKLET WARNS ABOUT POSSIBLY INADVERTENT KINKING AT THE HUB AREA WHEN SECURING THE CATHETER TO THE PT. THE KINKING MAY WEAKEN THE WALL OF THE CATHETER AND CAUSE FATIGUE OF THE MATERIAL LEADING TO POSSIBLE SEPARATION OF THE CATHETER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THEREFORE, THE POTENTIAL CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. THIS IS ONE OF 3 RECORDS REFLECTING MULTIPLE OCCURRENCES (B)(4). ADDITIONAL OCCURRENCES ARE DOCUMENTED AS MDR #1036844-2009-00100, MDR #1036844-2010-00073. UNTIL JULY 27, 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM (B)(6) 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(6) REPORTS. PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE FOLLOW-UP FOR THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE 5-INCH SILICONE SLEEVE THAT ATTACHES THE CATHETER TO THE HUB, WAS LEAKING AND EXPOSED TO AIR. THIS IS A REOCCURRING PROBLEM AND THERE ARE INTERMITTENT KITS WITHOUT THE REINFORCING SHEATH. THEY ALSO NOTED, THIS IS A CHANGE OUT OF PARTS ON THIS ARTERIAL LINE WITHOUT NOTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL LINE KIT ARTERIAL CATHETER PRODUCTS DQX ARROW INTERNATIONAL INC RF8111746

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK