BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 14 GA X 6" (16 CM)

    MDR report key: 16834790 · Received April 28, 2023

    Report

    Report Number
    3006425876-2023-00425
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 3, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    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 RETURNED ONE OPENED CVC KIT WITH MULTIPLE COMPONENTS , INCLUDING ONE ARROW RAULERSON SYRINGE (ARS), INTRODUCER NEEDLE , CATHETER, AND GUIDE WIRE ASSEMBLY. NO DEFINITE SIGNS OF USE WERE OBSERVED. VISUAL EXAMINATION OF THE ARS AND THE NEEDLE DID NOT REVEAL ANY OBVIOUS DEFECTS OR ANOMALIES. THE TIP OF THE SYRINGE WAS COMPARED TO A LAB INVENTORY ARS AND NO DIFFERENCES WERE NOTED. THE CONNECTION BETWEEN THE RETURNED SYRINGE AND NEEDLE WAS COMPARED WITH ANOTHER ARS SYRINGE AND INTRODUCER NEEDLE FROM LAB INVENTORY. THE RETURNED ARS SYRINGE WAS TESTED WITH A LAB INVENTORY NEEDLE, AND THE RETURNED NEEDLE WAS TESTED WITH A LAB INVENTORY ARS SYRINGE. THE RETURNED NEEDLE APPEARS TO BE FITTING LOOSELY ON BOTH THE RETURNED SYRINGE AND THE LAB INVENTORY SYRINGE. THE HUB OF THE NEEDLE WAS TESTED WITH THE MALE LUER GAUGE AND WAS WITHIN THE SPECIFIED RANGE. THIS INDICATES THAT THE LUER WAS CONFORMING PER ISO 80369-7. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND THREE RELEVANT FINDINGS WERE IDENTIFIED. FOR MATERIAL K-04300-019A/(B)(4) THREE NON-CONFORMANCES WERE INITIATED TO ADDRESS THE ISSUE OF SYRINGE/NEEDLE CONNECTION. THE COMPLAINT OF SYRINGE/NEEDLE CONNECTION NOT SECURE WAS ABLE TO BE CONFIRMED BY A COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. NO ISSUES WERE FOUND WITH THE DIMENSIONS OF THE RETURNED ARS AND INTRODUCER NEEDLE. BASED ON THE SAMPLE RETURNED, THIS ISSUE FALLS WITHIN THE SCOPE OF A PREVIOUSLY OPENED CAPA. THE CAPA IS IN THE INVESTIGATION PHASE AND THE ROOT CAUSE HAS NOT YET BEEN DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THE DOCTOR FOUND THE SYRINGE/NEEDLE CONNECTION NOT SECURE DURING PATIENT USE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DOCTOR FOUND THE SYRINGE/NEEDLE CONNECTION NOT SECURE DURING PATIENT USE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362577 ARROW CVC SET: 14 GA X 6" (16 CM) CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F21H1432

    Patients

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