BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRY SKIN PREP TRAY

    MDR report key: 11696909 · Received April 20, 2021

    Report

    Report Number
    3004932373-2021-00203
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 22, 2021
    Report Date
    October 13, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    OJU
    UDI-DI
    10885403142192
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE SUPPLIER, LOT NUMBER WAS REVIEWED AND NO ISSUES WERE FOUND. A SAMPLE WAS PROVIDED BY THE CUSTOMER AND IT WAS OBSERVED THAT HAIR WAS ON THE COMPONENT . THE FAILURE MODE WAS CONFIRMED WITH THE SAMPLE RECEIVED. THE ROOT CAUSE IS DUE TO MANUFACTURING PERSONNEL AS DRESS CODE WAS NOT FOLLOWED AND CAUSED THE CONTAMINATION. AN EMPLOYEE AWARENESS TRAINING WAS PERFORMED AT THE PLANT TO ENSURE THIS IS AN ISOLATED INCIDENT. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 4461A, BATCH NO.: 0004173982. IT WAS REPORTED THAT A HAIR WAS FOUND IN THE TRAY BEFORE USE. PER EMAIL: CAN YOU FORWARD THIS QUALITY ISSUE TO THE BD REP. OR FOUND A HAIR IN THE DRY PREOP SKIN PREP TRAY. ECH # 007202, REF# 4461A, LOT # 004173982. IT WAS ATTACHED TO ONE OF THE SPONGE STICKS. SEE BELOW.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    MATERIAL NO.: 4461A, BATCH NO.: 0004173982. IT WAS REPORTED THAT A HAIR WAS FOUND IN THE TRAY BEFORE USE. PER EMAIL: CAN YOU FORWARD THIS QUALITY ISSUE TO THE BD REP. OR FOUND A HAIR IN THE DRY PREOP SKIN PREP TRAY. ECH # 007202, REF# 4461A, LOT # 004173982. IT WAS ATTACHED TO ONE OF THE SPONGE STICKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592545 DRY SKIN PREP TRAY DRY SKIN PREP TRAY OJU CAREFUSION, INC 4461A 0004173982 10885403142192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other