BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 11730054 · Received April 26, 2021

    Report

    Report Number
    3004932373-2021-00215
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    March 31, 2021
    Report Date
    August 17, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE PROVIDED FOR EVALUATION. UNFORTUNATELY, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITE ROOT CAUSE. A DEVICE RECORD REVIEW WAS COMPLETED ON THE BATCH/LOT 0140871 AND A NON-CONFORMANCE FOUND DURING THE MANUFACTURING OF THE LOT AND DURING ONE OF THE ROUTINE QA INSPECTIONS. THE NON-CONFORMANCE FOUND WAS RELATED TO FOREIGN MATERIAL. A QUALITY NOTIFICATION WAS OPENED DUE TO A SUPPLIER ISSUE. THE SUPPLIER COMMUNICATED THAT THE SOLUTION LOT WAS POTENTIALLY AFFECTED BY A MICROBIOLOGICAL CONTAMINATION. THE PRODUCT WAS PLACED ON HOLD AND A SITUATIONAL ANALYSIS WAS PERFORMED TO EVALUATE THE RISK OF THE POTENTIAL CONTAMINATION. IT WAS CONCLUDED THAT THERE WAS NO RISK OF CONTAMINATION. POSSIBLE CAUSES INCLUDE: INCREASED CHG CONCENTRATION, INCREASED IPA CONCENTRATION, CHEMICAL SPECIFICATIONS DO NOT MEET REQUIREMENTS, INCREASED IMPURITY OR LEACHABLE CONCENTRATIONS. CURRENT CONTROLS INCLUDE CHEMISTRY TESTING PRIOR TO RELEASE. RISK IS DEEMED ACCEPTABLE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    MATERIAL NO.: 931490. BATCH NO.: 0140871. IT WAS REPORTED RASH APPEARED ON DONOR'S ARM POST USE. PER (B)(4). (B)(4) IS DESCRIBED AS "RASH APPEARED ON DONOR'S ARM POST USE". (B)(4) IS DESCRIBED AS "REDNESS APPEARED ON DONOR'S ARM IMMEDIATELY POST USE OF CHLORAPREP".

    Additional Manufacturer Narrative · 1

    (B)(4). PR (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.: 931490 BATCH NO.: 0140871. IT WAS REPORTED RASH APPEARED ON DONOR'S ARM POST USE. PER (B)(4). ADR 31/03 IS DESCRIBED AS "RASH APPEARED ON DONOR'S ARM POST USE". ADR 14/04 IS DESCRIBED AS "REDNESS APPEARED ON DONOR'S ARM IMMEDIATELY POST USE OF CHLORAPREP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618644 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0140871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other