BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 11797437 · Received May 10, 2021

    Report

    Report Number
    3004932373-2021-00237
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 12, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE PROVIDED FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. 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. A PRODUCTION BATCH HISTORY RECORDS FOR APPLICATOR PN 312480 LOT NUMBER 0286480 WERE REVIEWED AND NO NON-CONFORMITIES, FAILURES, DEVIATIONS, OR REWORK ACTIVITIES OCCURRED DURING THE MANUFACTURING OF THIS LOT SIMILAR TO THE REPORTED ISSUE OR THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. RECORDS REVIEWED INDICATE THAT THE LOT PASSED ALL THE IN-PROCESS INSPECTIONS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT: SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    TWO OCCURRENCES REPORTED. OCCURRENCE 2021/0002131: WHEN OPENING THE CHLORAPREP APPLICATOR, IT WAS WITHOUT SOLUTION (DRY); OCCURRENCE 2021/0002072: WHEN USING THE CHLORAPREP, IT HAS NO LIQUID.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TWO OCCURRENCES REPORTED. OCCURRENCE (B)(6) 2021: WHEN OPENING THE CHLORAPREP APPLICATOR, IT WAS WITHOUT SOLUTION (DRY); OCCURRENCE (B)(6) 2021: WHEN USING THE CHLORAPREP, IT HAS NO LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691992 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0286480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other