BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI-LUMEN/PSI SET

    MDR report key: 9871944 · Received March 24, 2020

    Report

    Report Number
    3006425876-2020-00260
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    December 28, 2019
    Report Date
    March 11, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K002507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED SEVERAL COMPONENTS FROM A MULTI-LUMEN PSI KIT. NO DEFINITE SIGNS-OF-USE WERE OBSERVED. THE DILATOR BODY LENGTH FROM THE HUB TO THE TIP MEASURED 8 1/8", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 8 1/32"-8 9/32" PER THE DILATOR GRAPHIC. THE DILATOR OUTER DIAMETER MEASURED .118", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .117"-.120" PER THE DILATOR EXTRUSION GRAPHIC. THE DILATOR INNER DIAMETER MEASURED .052", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .051"-.055" PER THE DILATOR EXTRUSION GRAPHIC. 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. THE IFU PROVIDED WITH THE KIT INFORMS THE USER , "ENLARGE CUTANEOUS PUNCTURE SITE WITH CUTTING EDGE OF SCALPEL POSITIONED AWAY FROM THE SPRING-WIRE GUIDE". THE IFU ALSO STATES, "DO NOT WITHDRAW DILATOR UNTIL THE ACCESS DEVICE IS WELL WITHIN THE VESSEL TO MINIMIZE THE RISK OF DAMAGING THE CATHETER TIP". THE CUSTOMER REPORT OF A DAMAGED DILATOR TIP WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE DILATOR TIP WAS FLATTENED AND FOLDED OUTWARD, WHICH IS DAMAGE CONSISTENT WITH UNDUE FORCE BEING APPLIED TO THE DILATOR TIP DURING AN ATTEMPTED INSERTION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON SALES HISTORY, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE CUSTOMER REPORTS AND THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE HEAD OF THE DILATOR WAS TORN. THE DOCTOR USED A NEW PRODUCT AND COMPLETED THE PROCEDURE WITHOUT INCIDENT.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). POTENTIAL LOT#: 71F18C0280.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE HEAD OF THE DILATOR WAS TORN. THE DOCTOR USED A NEW PRODUCT AND COMPLETED THE PROCEDURE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337121 ARROW MULTI-LUMEN/PSI SET CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1