BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ARTERIAL CATH SET: 18GA X 12CM

    MDR report key: 20842139 · Received December 4, 2024

    Report

    Report Number
    3006425876-2024-01203
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 20, 2024
    Report Date
    November 20, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    10801902129946
    PMA / PMN Number
    K171146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE CUSTOMER PROVIDED FOUR PHOTOS FOR ANALYSIS. THE PHOTOS SHOW THE ARTERIAL CATHETER WITHIN THE GUIDE WIRE, AND THE CATHETER HAS SEPARATED INTO MULTIPLE PIECES. THE RETURNED DEVICE DOES NOT MATCH THE CUSTOMER PHOTOS. THE CUSTOMER ALSO RETURNED ONE, UNOPENED ARTERIAL CATHETERIZATION SET FOR ANALYSIS. NO OBVIOUS SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS, DISCOLORATION OR ANOMALIES WITH THE RETURNED SAMPLE. THE CATHETER LENGTH FROM THE JUNCTURE HUB TO THE DISTAL TIP MEASURED 124 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 122-126 MM PER CATHETER PRODUCT DRAWING. THE CATHETER BODY OUTER DIAMETER MEASURED 1.25 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 1.24-1.30 MM PER CATHETER PRODUCT DRAWING. MANIPULATION OF THE CATHETER DID NOT REVEAL ANY EXCESSIVE BRITTLENESS, AND THE CATHETER FLEXED/BENT AS EXPECTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE CURRENT APPROVED PRODUCT LABELING FOR FINISHED GOOD SAC-01218-PBX WAS REVIEWED AND LABEL PART NUMBER LBL058221 INCLUDES THE ISO 15223-1 SYMBOL INDICATING "KEEP AWAY FROM SUNLIGHT." THE CUSTOMER REPORT OF ARTERIAL CATHETER SEPARATION WAS NOT CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS, DISCOLORATION OR ANOMALIES ON THE RETURNED CATHETER. THE RETURNED CATHETER MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, MANIPULATION OF THE CATHETER DID NOT REVEAL ANY EXCESSIVE BRITTLENESS, AND THE CATHETER FLEXED/BENT AS EXPECTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED TO SUGGEST A MANUFACTURING ISSUE. BASED ON THESE CIRCUMSTANCES, NO PROBLEM WAS FOUND. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "WE OBSERVED THAT ARTERIAL CATHETERS FRAGMENTED AS SOON AS CATHETERS WERE HANDLED/TOUCHED. THE "DISINTEGRATION" OF THE CATHETERS WAS VISIBLE BEFORE USE ON ANY PATIENT. NO PATIENT WAS INVOLVED BY THIS INCIDENT. IT HAPPENED ON MORE THAN 3 DEVICES." ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-01187,3006425876-2024-01204.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839132 ARROW ARTERIAL CATH SET: 18GA X 12CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F22E1897 10801902129946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED