BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP

    MDR report key: 10429508 · Received August 20, 2020

    Report

    Report Number
    3004932373-2020-00003
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    August 17, 2020
    Report Date
    November 20, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. UNFORTUNATELY, AS A RESULT, THE FAILURE MODE COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. A VISUAL INSPECTION OF THE RETAINED SAMPLES WAS PERFORMED, NO FOREIGN MATTER OR HAIR WAS NOTED. SAMPLES WERE CONFORMING. AFTER THE INSPECTION, THE RETAINED SAMPLES WERE RETURNED TO THE RETENTION INVENTORY. PRODUCTION RECORD REVIEW WAS COMPLETED FOR LOTS 0052505 AND 0050039 AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THESE LOTS. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    PER NOTIFICATION STATED RN STATED THAT THEY RECEIVED A KIT THAT CONTAINED A HAIR AND IT WAS STUCK INTO THE CHLORAPREP SWAB.

    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

    PER NOTIFICATION STATED. RN STATED THAT THEY RECEIVED A KIT THAT CONTAINED A HAIR AND IT WAS STUCK INTO THE CHLORAPREP SWAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899700 CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other