BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP

    MDR report key: 11108657 · Received January 4, 2021

    Report

    Report Number
    3004932373-2020-00169
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    December 9, 2020
    Report Date
    March 9, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES AND PHOTOS WERE PROVIDED FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED SAMPLES AND PHOTOS INDEED SHOW THE REPORTED FAILURE MODE OF HAIR INSIDE THE UNOPENED PACKAGE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) DURING THE MANUFACTURING OF THE PRODUCT. GOWNING PROCEDURES REQUIRE OPERATORS TO WEAR HAIR NETS, GLOVES, SAFETY GLASSES AND HEAD COVERS. IF PROTECTIVE EQUIPMENT IS WORN IMPROPERLY IT IS POSSIBLE FOR ASSOCIATES TO ACCIDENTALLY SHED HAIR ONTO THE PRODUCT AS THEY ARE LOADING COMPONENTS INTO THEIR CORRESPONDING CONTAINERS/PACKAGES. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) DURING THE MANUFACTURING OF THE PRODUCT. PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 0192995 AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A LARGE HAIR INSIDE THE STERILE PACKAGING. A LARGE HAIR INSIDE THE STERILE PACKAGING

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO.: 930480 . BATCH NO.: 0192995. IT WAS REPORTED THERE WAS A LARGE HAIR INSIDE THE STERILE PACKAGING. A LARGE HAIR INSIDE THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9106 CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 0192995

    Patients

    Seq Age Sex Outcome Treatment
    1 Other