BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHENA 18GX1.25IN STRAIGHT BC

    MDR report key: 19462176 · Received June 4, 2024

    Report

    Report Number
    2243072-2024-00675
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    May 13, 2024
    Report Date
    May 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903868018
    PMA / PMN Number
    K220584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CATHENA 18GX1.25IN STRAIGHT BC SMALL PIECE OF PLASTIC OR GLUE STUCK INSIDE THE BEVEL OF CANNULA. SMALL PIECE OF PLASTIC OR GLUE STUCK INSIDE THE BEVEL OF CANNULA. HSS HAS RECEIVED A PRODUCT COMPLAINT FROM (B)(4) HOSPITAL, SEE PRODUCT DETAIL BELOW: PRODUCT: BD CATHENA 18GA 1.25 IN. SUPPLIER: (B)(4). COMPLAINT: ["STERILITY/CONTAMINATION OR LEAKAGE ISSUE","MANUFACTURING FAULT?"] DESCRIPTION: SMALL PIECE OF PLASTIC OR GLUE STUCK INSIDE THE BEVEL OF CANNULA. ACTION: DISCARDED AND USED DIFFERENT ITEM AND INSPECTED FOR FOREIGN MATERIAL. TOOK PHOTOS OF PRODUCT THEN DISCARDED. COMPLAINANT: (B)(6). CONTACT NUMBER: (B)(6). ALTERNATIVE CONTACT: (B)(6). IS PRODUCT AVAILABLE? NO. IS PACKAGING AVAILABLE? NO. WE REQUEST A SOLUTION TO THIS COMPLAINT, ALONG WITH REPLACEMENT PRODUCTS OR A CREDIT REIMBURSEMENT BY THE KPI DEADLINE OF 11 JUNE 2024. ALL COMMUNICATIONS REGARDING THIS ISSUE SHOULD ALSO BE EMAILED TO MAILTO:HSS.(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610028 BD CATHENA 18GX1.25IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 2174805 00382903868018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown