BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA

    MDR report key: 6821548 · Received August 25, 2017

    Report

    Report Number
    1645337-2017-00064
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    September 26, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 140213-02 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER'S REF. NO: (B)(4) UPON RECEIPT IT WAS OBSERVED THAT THE TIP OF THE CANNULA WAS MISSING, MEASURING APPROXIMATELY 24.8CM FROM THE HUB. COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF BECKER TEAR DROP ONE-PIECE CANNULA (REUSABLE) 3 MM 26 CM LONG HANDLE WAS BROKEN. THE CANNULA WAS REMOVED FROM THE PATIENT BODY WITHOUT INJURY. THE PRODUCT HAD TO BE REPLACED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602813 CANNULA CAN MENTOR WORLDWIDE LLC 140213-02

    Patients

    Seq Age Sex Outcome Treatment
    1