BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 13691933 · Received March 8, 2022

    Report

    Report Number
    3004932373-2022-00068
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 8, 2022
    Report Date
    May 4, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    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) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 0

    4464106BASED ON NO PHOTOGRAPH OR SAMPLE WAS RECEIVED FOR ANALYSIS FROM THE CUSTOMER, THE FAILURE MODE COULD NOT BE CONFIRMED. THE AMPOULE IS MADE OF GLASS AND IS DESIGNED TO BREAK AT A RELATIVELY LOW BREAK FORCE. WHEN PRESSURE IS APPLIED TO THE WINGS BY A PINCHING FORCE WITH THE FINGERS, THIS ACTIVATES THE APPLICATOR; BREAKING THE GLASS AMPOULE AND RELEASING THE CHLORAPREP SOLUTION ONTO THE FOAM TIP. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO POST MANUFACTURING HANDLING, WHICH CAN PROVIDE ENOUGH FORCE/IMPACT TO ACTIVATE AND BREAK THE GLASS AMPOULE. DUE TO THE NATURE OF GLASS IT IS POSSIBLE TO HAVE AN ACTIVATED APPLICATOR AND/OR BROKEN AMPOULE IF THE APPLICATOR UNDERGOES EXCESSIVE HANDLING. WITHOUT THE ACTUAL SAMPLE A ROOT CAUSE CAN'T BE DETERMINED. NO FURTHER ACTION WILL BE TAKEN BASED ON NO ADVERSE TREND HAS BEEN OBSERVED. WILL CONTINUE TO TRACK & TREND FOR THIS DEFECT.

    Description of Event or Problem · 0

    MATERIAL #930500NSB. BATCH #1253363. IT WAS REPORTED THAT THE CHLORAPREP CAME IN THE PACK DRY. VERBATIM: THE CHLORAPREP CAME IN THE PACK DRY. IT WASN'T DEPLOYED ALREADY, IT WAS JUST DRY. RECEIVED VIA : EMAIL (B)(6). EXTERNAL REFERENCE # (B)(4). DATE OF EVENT- (B)(6) 2022. # OF OCCURRENCES - 4. EMAIL VERBATIM: COMPLAINT NUMBER: (B)(4). CREATED DATE 02-09-22. EVENT DATE (B)(6) 2022. MANUFACTURING SITE JRZ. PRODUCT MALFUNCTION/FAILURE MODE DRY. PRODUCT DESCRIPTION SUMMARY: THE CHLORAPREP CAME IN THE PACK DRY. IT WASN'T DEPLOYED ALREADY, IT WAS JUST DRY. COMPLAINT QUANTITY 4. SAMPLE AVAILABLE: YES. PRESOURCE COMPONENT # 930500NSB~PSPRMS. MFG. SKU NUMBER: 930500NSB. COMPONENT NAME: APPLICATOR,PREP,CHLORAPREP,3ML,CLEAR,STER SOL,NS. INVESTIGATED COMPONENT LOT NUMBER: 1253363. WAS THERE AN INJURY: NO. WAS THERE A DEATH : NO.

    Description of Event or Problem · 0

    MATERIAL #930500NSB. BATCH #1253363. IT WAS REPORTED THAT THE CHLORAPREP CAME IN THE PACK DRY. VERBATIUM: THE CHLORAPREP CAME IN THE PACK DRY. IT WASN'T DEPLOYED ALREADY, IT WAS JUST DRY. RECEIVED VIA : (B)(4). EXTERNAL REFERENCE # (B)(4). DATE OF EVENT- 08 FEBRUARY 2022. # OF OCCURRENCES - 4. EMAIL VERBATIM: COMPLAINT NUMBER: (B)(4). CREATED DATE: 02-09-22. EVENT DATE: 02-08-22. MANUFACTURING SITE: JRZ. PRODUCT MALFUNCTION/FAILURE MODE: DRY. PRODUCT DESCRIPTION SUMMARY: THE CHLORAPREP CAME IN THE PACK DRY. IT WASN'T DEPLOYED ALREADY, IT WAS JUST DRY. COMPLAINT QUANTITY: 4. SAMPLE AVAILABLE: YES. PRESOURCE COMPONENT #: 930500NSB~PSPRMS MFG. SKU NUMBER: 930500NSB. COMPONENT NAME: APPLICATOR,PREP,CHLORAPREP,3ML,CLEAR,STER SOL,NS. INVESTIGATED COMPONENT LOT NUMBER: 1253363. WAS THERE AN INJURY: NO. WAS THERE A DEATH: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656163 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 1253363

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other