BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP CLEAR

    MDR report key: 12971145 · Received December 9, 2021

    Report

    Report Number
    3004932373-2021-00531
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    December 2, 2021
    Report Date
    June 6, 2024
    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

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

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, A PROBABLY ROOT CAUSE IS THAT THE AMPOULES WERE PRE-ACTIVATED, HOWEVER THIS COULD NOT BE CONFIRMED AS NO SAMPLES WERE RECEIVED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ADDENDUM: THIS SUBMISSION IS A CORRECTION TO INCLUDE IMDRF CODES THAT WERE NOT PROVIDED IN THE PRIOR REPORT.

    Description of Event or Problem · 0

    MATERIAL NO: 930500NSB BATCH NO: 1088484, 1081844, AND 1044870. IT WAS REPORTED THAT THE CHLORAPREP APPLICATOR USED FOR CLEANING IS DRIED. VERBATIM: I WORK FOR MEDLINE AT DIVISION 20 (CENTURION MEDICAL) AND WE PURCHASE YOUR 3 ML CHLORAPREP APPLICATOR (COMPONENT 930500NSB). I WANTED TO NOTIFY YOU THAT WE HAVE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMERS. THE COMPLAINT REPORT STATED THE FOLLOWING: THE CHLORAPREP APPLICATOR USED FOR CLEANING IS DRIED. THE COMPONENT INFORMATION IS THE FOLLOWING: CENTURION MATERIAL NO.: 136719. PO NOS.: 6000005444, 6000005133, AND 6000004438. VENDOR MATERIAL NO.: 930500NSB. VENDOR LOTS NOS.: 1088484, 1081844, 1AND 044870. UNFORTUNATELY, NEITHER A SAMPLE OR PICTURE COULD BE PROVIDED BY THE CUSTOMER. COULD YOU FIND OUT IF THERE HAVE BEEN SIMILAR COMPLAINTS REPORTED AND EVALUATE RETAINS/PRODUCTION RECORDS? IF YOU HAVE ADDITIONAL INSIGHT OR INFORMATION THAT COULD BE USED FOR THE INVESTIGATION, PLEASE LET ME KNOW.

    Description of Event or Problem · 0

    MATERIAL NO: 930500NSB. BATCH NO: 1088484, 1081844, 1044870. IT WAS REPORTED THAT THE CHLORAPREP APPLICATOR USED FOR CLEANING IS DRIED. VERBATIM: I WORK FOR MEDLINE AT DIVISION 20 (CENTURION MEDICAL) AND WE PURCHASE YOUR 3 ML CHLORAPREP APPLICATOR (COMPONENT 930500NSB). I WANTED TO NOTIFY YOU THAT WE HAVE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMERS. THE COMPLAINT REPORT STATED THE FOLLOWING: THE CHLORAPREP APPLICATOR USED FOR CLEANING IS DRIED. THE COMPONENT INFORMATION IS THE FOLLOWING: CENTURION MATERIAL NO.: 136719. PO NOS.: (B)(6). VENDOR MATERIAL NO.: 930500NSB. VENDOR LOTS NOS.: 1088484, 1081844, 1044870. UNFORTUNATELY, NEITHER A SAMPLE OR PICTURE COULD BE PROVIDED BY THE CUSTOMER. COULD YOU FIND OUT IF THERE HAVE BEEN SIMILAR COMPLAINTS REPORTED AND EVALUATE RETAINS/PRODUCTION RECORDS? IF YOU HAVE ADDITIONAL INSIGHT OR INFORMATION THAT COULD BE USED FOR THE INVESTIGATION, PLEASE LET ME KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864267 CHLORAPREP ONE STEP CLEAR 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1081844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other