BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JACKSON-PRATT DRAIN

    MDR report key: 1862205 · Received October 4, 2010

    Report

    Report Number
    1862205
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 1, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    JCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6), FEMALE, ADMITTED TO THE MEDICAL CENTER ON (B)(6), 2010 FOR TREATMENT RELATED TO A PROBABLE OVARIAN MASS. ON (B)(6), 2010, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY. A JACKSON-PRATT DRAIN WAS PLACED DURING THE OPERATION. ON (B)(6), 2010, A NURSING UNIT MANAGER REPORTED BY PHONE THAT A PHYSICIAN ATTEMPTED TO PULL THE JACKSON-PRATT DRAIN FROM THE PATIENT'S ABDOMEN AND THE TUBE BROKE. THE RETAINED FRAGMENT RETRACTED REQUIRING SURGICAL REMOVAL. THE PHYSICIAN REPORTED THAT SHE DID NOT PULL THE DRAIN ANY HARDER THAN USUAL FOR REMOVING THESE DRAINS. SHE HAS PULLED MANY OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON-PRATT DRAIN BULB DRAIN JCY C.R. BARD, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention