BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD BONNANO¿ SUPRAPUBIC CATHETER TRAY

    MDR report key: 6355477 · Received February 23, 2017

    Report

    Report Number
    2618282-2017-00001
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    February 9, 2017
    Report Date
    February 23, 2017
    Manufacturer
    BD CARIBE LTD.
    Product Code
    FEZ
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN SUFFERED A CONTAMINATED NEEDLE STICK INJURY FROM AN 18 GAUGE NEEDLE IN A BD BONNANO SUPRAPUBIC CATHETER TRAY. THE PHYSICIAN FOLLOWED PROTOCOL FOR AN OCCUPATIONAL BLOOD EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135401 BD BONNANO¿ SUPRAPUBIC CATHETER TRAY SUPRAPUBIC CATHETER FEZ BD CARIBE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention