BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 10934885 · Received December 2, 2020

    Report

    Report Number
    3004932373-2020-00141
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    October 29, 2020
    Report Date
    January 29, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE AND A ROOT CAUSE COULD NOT BE DEFINED. PRODUCTION RECORD REVIEW HAS BEEN COMPLETED FOR BATCH/LOT 9243915 AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED. SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 260715 BATCH NO.: 9243915. IT WAS REPORTED THAT THE CHLORAPREP WAS LEAKING INSIDE THE STERILE POUCH. PER EMAIL: CASE (B)(4) (B)(6) 2020 (B)(6) 2020 EP-DH LEAK CHLORAPREP WAS LEAKING INSIDE STERILE POUCH. 1 YES 260715ZP~PSPRMS 260715, DISC USE 930715P (070720)APPLICATOR,PREP,CHLORAPREP,2% 9243915 NO.

    Additional Manufacturer Narrative · 1

    PR (B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    MATERIAL NO.: 260715 BATCH NO.: 9243915 IT WAS REPORTED THAT THE CHLORAPREP WAS LEAKING INSIDE THE STERILE POUCH. PER EMAIL: (B)(4). (B)(6) 2020 EP-DH LEAK CHLORAPREP WAS LEAKING INSIDE STERILE POUCH. 1 YES 260715ZP~PSPRMS 260715 DISC USE 930715P (070720)APPLICATOR,PREP,CHLORAPREP,2% 9243915 NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399895 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION, INC 9243915

    Patients

    Seq Age Sex Outcome Treatment
    1 Other