BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 17481563 · Received August 8, 2023

    Report

    Report Number
    3006425876-2023-00754
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 12, 2023
    Report Date
    July 12, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    00801902102362
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). THE CUSTOMER PROVIDED FIVE PHOTOS AND ONE VIDEO FOR ANALYSIS. THE PHOTOS AND VIDEO CONFIRM THAT THERE WERE FOREIGN PARTICULATES COMING FROM INSIDE THE ARROW RAULERSON SYRINGE (ARS) VALVE. THE CUSTOMER ALSO RETURNED AN OPENED CVC KIT INCLUDING AN INTRODUCER NEEDLE , GUIDE WIRE ASSEMBLY, AND AN ARS FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THERE WERE NO SIGNS OF USE OBSERVED. FOREIGN MATERIAL WAS OBSERVED ON THE GUIDE WIRE ASSEMBLY AND WITHIN THE ARS HANDLE. MICROSCOPIC EXAMINATION CONFIRMED THE FOREIGN MATERIAL INSIDE THE ARS HANDLE AND ON THE GUIDE WIRE ASSEMBLY. THE SAMPLE WAS SENT FOR FTIR TESTING OF THE FOREIGN MATERIAL. THE MATERIAL MATCHES THOSE OF POLY-ISOPRENE OR STYRENE ISOPRENE. R & D STATED THAT THE ONLY COMPONENT IN THE FINISHED GOOD KIT WOULD BE THE WIRE SNUBBER (K-04210-003A) FOUND ON THE SWG ASSEMBLY. THE MATERIAL USED IS STYRENE COPOLYMER WHICH MATCHED WITH THE FTIR REPORT. IN ADDITION , "WIRE SNUBBERS ARE RECEIVED IN BULK NON-STERILE IN POLYBAGS. SO IT IS POSSIBLE THAT SOME SMALL PARTICLES MADE INTO THE KIT." A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE COMPLAINT OF FOREIGN MATERIAL INSIDE DEVICE WAS CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED FOREIGN MATERIAL WAS OBSERVED ON THE GUIDE WIRE ASSEMBLY AND WITHIN THE ARS HANDLE. FTIR ANALYSIS PERFORMED REVEALED THAT THE MATERIAL PROFILE IS CONSISTENT WITH THE WIRE SNUBBER COMPONENT. BASED ON WIRE SNUBBER BEING A PURCHASED COMPONENT, THE ROOT CAUSE WAS DETERMINED TO BE SUPPLIER RELATED. A NON-CONFORMANCE WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THE PHYSICIAN FOUND FOREIGN MATERIAL INSIDE THE ARROW RAULERSON SYRINGE WHEN THE PHYSICIAN WITHDREW THE SPRING WIRE GUIDE FROM THE SYRINGE. THE ISSUE WAS DETECTED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT WITH THE DEVICE WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PHYSICIAN FOUND FOREIGN MATERIAL INSIDE THE ARROW RAULERSON SYRINGE WHEN THE PHYSICIAN WITHDREW THE SPRING WIRE GUIDE FROM THE SYRINGE. THE ISSUE WAS DETECTED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT WITH THE DEVICE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317976 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F22H1871 00801902102362

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.| N/A.