BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREP TRAY DRY SPONGE W/GLOVE

    MDR report key: 7003165 · Received November 6, 2017

    Report

    Report Number
    8030673-2017-00263
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 3, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    OJU
    PMA / PMN Number
    D120879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INITIAL/FINAL EMDR SUBMISSION, SHOULD FURTHER INFORMATION BE RECEIVED A FOLLOW UP WILL BE SUBMITTED. SAMPLE WAS NOT RECEIVED BY THE CUSTOMER FOR EVALUATION. THE DEVICE HISTORY RECORD STATED THAT THE LOT NUMBER IN QUESTION WAS MANUFACTURED WITHIN SPECIFICATION IN ACCORDANCE TO INTERNAL PROCEDURES, NO ISSUES RELATED TO THIS COMPLAINT WERE FOUND. QUALITY ENGINEERS STATED THAT THE CUSTOMER USED THE INCORRECT PART NUMBER FOR THE DESCRIBED PROCEDURE. PART NUMBER 4416A, IS NOT INTENDED FOR INTERNAL VAGINAL USE. THEREFORE THE MOST PROBABLE CAUSE IS DUE TO USER ERROR. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2017 TO ASK IF THERE HAD BEEN ANY CHANGES TO THE SPONGE STICKS IN THE BD DRY PREP TRAY, ITEM #4461A. STATED THAT PATIENT COMPLAINED OF ¿INTERNAL SCRATCHES¿ TO VAGINAL AREA POST VAGINAL PROCEDURE. PLEASE SEE QUESTIONS AND CUSTOMER RESPONSES (IN RED) BELOW WHICH I RECEIVED ON (B)(6): WHEN DID THIS HAPPEN? IN THE LAST 72 HOURS. THIS ISSUE OCCURRED WHILE PERFORMING A VAGINAL PREP ON THE PATIENT? YES. DID THE CLINICIAN NOTICE THE PLASTIC PART OF THE SPONGE STICK PROTRUDING WHEN IT WAS REMOVED FROM THE PATIENT? NO. DID THE ISSUE INVOLVE MORE THAN ONE OF THE SPONGE STICKS IN THE TRAY? UNCERTAIN. WERE THEY ABLE TO GET THE LOT NUMBER OFF THE TRAY AT ISSUE? NO. WHEN WAS THE PATIENT ISSUE IDENTIFIED? POST OP WHEN THE PATIENT COMPLAINED OF INTERNAL SCRATCHES. WERE THE ¿SCRATCHES¿ VISIBLE OR INTERNAL? INTERNAL. WAS ANY TREATMENT NEEDED? NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782242 PREP TRAY DRY SPONGE W/GLOVE SKIN PREP TRAY OJU CAREFUSION, INC 0001114851

    Patients

    Seq Age Sex Outcome Treatment
    1 Other