BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10632371 · Received October 5, 2020

    Report

    Report Number
    3006425876-2020-00859
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    July 6, 2020
    Report Date
    September 14, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED AN INTRODUCER NEEDLE FOR EVALUATION. THE CUSTOMER ALSO PROVIDED A PHOTO OF THE DETACHED NEEDLE CANNULA AND NEEDLE HUB. VISUAL EXAMINATION REVEALED THE NEEDLE CANNULA WAS SEPARATED FROM THE NEEDLE HUB. MICROSCOPIC EXAMINATION REVEALED SMALL TRACES OF ADHESIVE RESIDUE ON THE NEEDLE CANNULA. THERE WAS LITTLE TO NO ADHESIVE RESIDUE OBSERVED ON THE NEEDLE HUB. THE BLAST LENGTH ON THE NEEDLE CANNULA MEASURED 10MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 8.5MM-10.5MM PER THE CANNULA PRODUCT DRAWING. THE NEEDLE CANNULA OUTER DIAMETER MEASURED 0.050", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.050"-0.051" PER THE CANNULA GRAPHIC. THE CANNULA INNER DIAMETER MEASURED .041", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA PRODUCT DRAWING. THE INNER DIAMETER OF THE DISTAL END OF THE NEEDLE HUB MEASURED 0.059", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.0585-0.0605" PER THE HUB GRAPHIC. THE NEEDLE CANNULA WAS ABLE TO BE EASILY REMOVED AND RE-INSERTED INTO THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORT OF A NEEDLE CANNULA DETACHED FROM THE HUB IN USE WAS CONFIRMED BY THE CUSTOMER'S PHOTOS AND A COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE CANNULA HAD COMPLETELY DETACHED FROM THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE SAMPLE RECEIVED, MANUFACTURING (ASSEMBLY) CAUSED OR CONTRIBUTED TO THIS EVENT. A NON-CONFORMANCE WAS INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED " THE NEEDLE WAS SEPARATED FROM ARS DURING PUNCTURE ON THE PATIENT". NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED " THE NEEDLE WAS SEPARATED FROM ARS DURING PUNCTURE ON THE PATIENT". NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097198 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL INC. 71F19J0355

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.| NONE REPORTED.