BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 12055431 · Received June 23, 2021

    Report

    Report Number
    3004932373-2021-00302
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 13, 2021
    Report Date
    August 31, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOGRAPH RECEIVED FOR ANALYSIS SHOWS A CONFORMING APPLICATOR INSIDE THE ORIGINAL UNOPENED PACKAGE. FROM THE PHOTOGRAPH THE FAILURE MODE OF SOLUTION NOT ENOUGH COULD NOT BE CONFIRMED. THE LOT NUMBER REPORTED IS NOT A TRUE LOT NUMBER AND THE BATCH RECORD COULD NOT BE PERFORMED.COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 930815, BATCH NO.: 136710. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE APPLICATOR HAS VERY LITTLE LIQUID. PER EMAIL: WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING CHLORAPREP HAS VERY LITTLE LIQUID. PLEASE SEE THE BELOW DETAILS REGARDING THE REPORTED ISSUE. IF IT IS INDICATED THAT A SAMPLE IS AVAILABLE, PLEASE PROVIDE SHIPPING INSTRUCTIONS WITHIN 30 DAYS OR THE SAMPLE WILL BE DISPOSED OF. MEDLINE COMPLAINT #: (B)(4). DEFECT DESCRIPTION: CHLORAPREP HAS VERY LITTLE LIQUID. MEDLINE PART #: 136710. PRODUCT DESCRIPTION: CHLORAPREP APP 26ML ORANGE. VENDOR PART #: 930815. LOT #: 0. PO#: UNKNOWN. SAMPLE RECEIVED: NO. RESPONSE NEEDED: NO.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO.: 930815. BATCH NO.: 136710. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE APPLICATOR HAS VERY LITTLE LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944253 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other