BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 12178776 · Received July 15, 2021

    Report

    Report Number
    3004932373-2021-00330
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 23, 2021
    Report Date
    August 23, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER NOT SAMPLE WAS AVAILABLE, BD WAS UNABLE TO CONFIRM THE FAILURE MODE. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) AND/OR PREVENTIVE MEASURES DURING THE PACKAGING 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.AN INITIATIVE UNDER THE CURRENT CAPA IS TO REPLACE LAB COATS TO PREVENT HAIR FROM COMING INTO THE CONTROLLED MANUFACTURING ENVIRONMENT. BD WILL CONTINUE TO TRACK AND TREND FOLLOW UP EMDR FOR (B)(4).

    Description of Event or Problem · 0

    MATERIAL NO.: UNKNOWN. BATCH NO.: UNKNOWN. IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT HAIRS AND OTHER EXTRANEOUS MATTER INSIDE THE BLISTERS HAS BEEN AN ONGOING PROBLEM. PER EMAIL: I AM NOT SURE TO WHOM THIS QUERY SHOULD BE ADDRESSED. PLEASE FORWARD IT TO THE CORRECT PERSON AND LET ME KNOW WHO IT IS. I SEE FROM THE EXCEL SPREADSHEET THAT A COMPLAINT WAS RAISED DIRECTLY TO THE [OMITTED] CONCERNING A HAIR FOUND INSIDE A BLISTER PACK. THIS SEEMS TO HAVE BEEN SENT THROUGH THE YELLOW CARD SYSTEM. THE PRODUCT CONCERNED WAS 3ML CLEAR, BATCH NO. 0336169. THEY HAVE RAISED THEIR CASE REPORT. PLEASE COULD YOU LET ME KNOW WHAT FURTHER INFORMATION THEY HAVE ASKED FOR, WHAT HAS BEEN SENT AND BY WHOM? AS YOUR QPS, WE WOULD EXPECT TO HAVE BEEN INCLUDED IN THIS COMMUNICATION. I HAVE SEEN NO FURTHER INCIDENCES OF ANY PROBLEMS WITH THIS BATCH ¿ HAVE THERE BEEN ANY? THIS ISSUE WITH HAIRS AND OTHER EXTRANEOUS MATTER INSIDE THE BLISTERS HAS BEEN AN ONGOING PROBLEM FOR AS LONG AS I HAVE WORKED WITH CHLORAPREP, SOME 15 YEARS NOW, AND IT HAS NEVER REALLY BEEN FIXED. IS THERE ANYTHING ACTUALLY BEING DONE, OR DO YOU CONSIDER IT TO BE RARE ENOUGH TO IGNORE? I LOOK FORWARD TO HEARING FROM YOU SOON.

    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.: UNKNOWN. BATCH NO.: UNKNOWN. IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT HAIRS AND OTHER EXTRANEOUS MATTER INSIDE THE BLISTERS HAS BEEN AN ONGOING PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075777 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other