BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM

    MDR report key: 17913095 · Received October 11, 2023

    Report

    Report Number
    9680794-2023-00779
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    July 27, 2023
    Report Date
    September 14, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902112054
    PMA / PMN Number
    K011761
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    MEDWATCH FORM RECEIVED REPORTS: "LIJ 9 FR DL WITH CLIP IN TRIPLE LUMEN PLACED VIA US GUIDED AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND THEN REMOVED 13 DAYS LATER. NOTED BACKFLOW OF MEDICATION/BLOOD IN ONE OF THE CAPPED/CLAMPED LUMENS AND PINKNESS AROUND THE INSERTION SITE. SKIN PROGRESSED TO LOCALLY EDEMATOUS AND REDDENED. THE PATIENT ALSO REPORTED PAIN AT THE SITE. SKIN PINK, MILD IRRITATION, NO EVIDENCE OF UNDERLYING TISSUE INJURY. LINE NOT SAVED."

    Description of Event or Problem · 0

    MEDWATCH FORM RECEIVED REPORTS: "LIJ 9 FR DL WITH CLIP IN TRIPLE LUMEN PLACED VIA US GUIDED AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND THEN REMOVED 13 DAYS LATER. NOTED BACKFLOW OF MEDICATION/BLOOD IN ONE OF THE CAPPED/CLAMPED LUMENS AND PINKNESS AROUND THE INSERTION SITE. SKIN PROGRESSED TO LOCALLY EDEMATOUS AND REDDENED. THE PATIENT ALSO REPORTED PAIN AT THE SITE. SKIN PINK, MILD IRRITATION, NO EVIDENCE OF UNDERLYING TISSUE INJURY. LINE NOT SAVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180011 ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL LLC UNKNOWN 10801902112054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED.| NOT REPORTED.