BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARNS RIGID ADULT INTRACARDIAC SUCKER

    MDR report key: 109522 · Received July 31, 1997

    Report

    Report Number
    1828100-1997-00014
    Event Type
    Injury
    Date Received
    July 31, 1997
    Date of Event
    June 25, 1997
    Report Date
    July 30, 1997
    Manufacturer
    3M HEALTH CARE SARNS AND CDI PRODUCTS
    Product Code
    DTS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE, THE TIP OF THE SUCKER FELL OFF AND DROPPED INTO THE PATIENT'S THORACIC CAVITY. THE TIP WAS RETRIEVED AFTER THE INCIDENT. A PLASTIC RETAINING COLLAR, WHICH NORMALLY HOLDS THE TIP IN PLACE ON THE SUCKER, WAS MISSING. BECAUSE OF ITS SIZE, IT IS UNLIKELY THAT THE COLLAR ALSO DROPPED INTO THE PATIENT AND WAS NOT RECOVERED. THERE HAS BEEN NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS RIGID ADULT INTRACARDIAC SUCKER SUCKER DTS 3M HEALTH CARE SARNS AND CDI PRODUCTS 98-0702-0442-9 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention