BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-L 15 FR X 55 CM RETR

    MDR report key: 14525441 · Received May 27, 2022

    Report

    Report Number
    9680794-2022-00339
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 9, 2022
    Report Date
    May 9, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    MSD
    PMA / PMN Number
    K141051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    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.

    Description of Event or Problem · 0

    CUSTOMER REPORTS ISSUE WITH CATHETER KINKING AND NEEDING TO BE REPLACED A DAY AFTER INSERTION. CUSTOMER REPORTS THE ISSUE HAS BEEN OCCURING SINCE (B)(6) 2021 AND COULD NOT PROVIDE ANY FURTHER PATIENT OR EVENT DETAILS.

    Description of Event or Problem · 0

    CUSTOMER REPORTS ISSUE WITH CATHETER KINKING AND NEEDING TO BE REPLACED A DAY AFTER INSERTION. CUSTOMER REPORTS THE ISSUE HAS BEEN OCCURING SINCE AUGUST 2021 AND COULD NOT PROVIDE ANY FURTHER PATIENT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266891 ARROW HEMODIALYSIS SET: 2-L 15 FR X 55 CM RETR CATHETER, HEMODIALYSIS, IMPLA MSD ARROW INTERNATIONAL LLC UNKNOWN

    Patients

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