BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP

    MDR report key: 10895673 · Received November 24, 2020

    Report

    Report Number
    3004932373-2020-00132
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 31, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE NOT PROVIDED FOR EVALUATION. UNFORTUNATELY, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE. A DEFINED ROOT CAUSE COULD NOT BE ESTABLISHED. PRODUCT RECORD REVIEW FOR LOT 0048402 AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT. OUR RECORDS INDICATE THAT THE REVIEWED BATCH RECORD PASSED ALL THE IN-PROCESS INSPECTION. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    MATERIAL NO.: 930299, LOT NO.: 0048402. IT WAS REPORTED THAT THERE WAS NOT ENOUGH FLUID IN THE CARTRIDGE LEADING TO DRY SWABS. BD REP, (B)(4) CALLED ON BEHALF OF CUSTOMER. *NOTE- BD REP TRIED TO SEND COMPLAINT THROUGH SALESFORCE, BUT STATED HE RECEIVED AN ERROR, AND IT DID NOT GO THROUGH.* CUSTOMER REPORTED THAT THEY FOUND TWO SWABS TO BE DRY- THERE WAS NOT ENOUGH FLUID IN THE CARTRIDGES. DOE: (B)(6) 2020. THIS WAS BEFORE USE AND THERE WERE NO ADVERSE EVENTS REPORTED. PLEASE CONTACT CUSTOMER, COPY (B)(4) ON FOLLOW UP EMAIL TO CUSTOMER. PLEASE CC (B)(4).

    Additional Manufacturer Narrative · 1

    PR (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.: 930299 LOT NO.: 0048402 IT WAS REPORTED THAT THERE WAS NOT ENOUGH FLUID IN THE CARTRIDGE LEADING TO DRY SWABS. BD REP, (B)(4) CALLED ON BEHALF OF CUSTOMER. NOTE- BD REP TRIED TO SEND COMPLAINT THROUGH SALESFORCE, BUT STATED HE RECEIVED AN ERROR, AND IT DID NOT GO THROUGH. CUSTOMER REPORTED THAT THEY FOUND TWO SWABS TO BE DRY- THERE WAS NOT ENOUGH FLUID IN THE CARTRIDGES. DOE: (B)(6) 2020. THIS WAS BEFORE USE AND THERE WERE NO ADVERSE EVENTS REPORTED. PLEASE CONTACT CUSTOMER, COPY (B)(4) ON FOLLOW UP EMAIL TO CUSTOMER. PLEASE CC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360334 CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 0048402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other