BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 12264620 · Received August 3, 2021

    Report

    Report Number
    3004932373-2021-00353
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 5, 2021
    Report Date
    August 30, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD FOR PN 930415 LN 1134389 WAS REVIEWED AND THERE WERE NO DEFECTS FOUND FOR MISSING PRINT BECAUSE PART NUMBER 930415 DOES NOT REQUIRE A PRINT ON THE APPLICATOR. IN ACCORDANCE TO OUR INTERNAL PROCEDURES, THE ONLY 3ML PART NUMBERS THAT REQUIRE A PRINT ON THE APPLICATOR ARE THE FOLLOWING: 260415NSB, 930415NSB, 260500NS, 930500NSB, WHICH ARE ALL PRODUCTS THAT ARE NOT PACKAGED AND ARE SOLD IN BULK. THE LOT NUMBER AND EXPIRATION DATE ARE PRINTED ON THESE PART NUMBERS SINCE THEY ARE NOT PACKAGED. LOT NUMBER AND EXPIRATION DATE FOR PACKAGED PRODUCT (LIKE 930415) IS EMBOSSED UNTO THE POUCH THAT CONTAINS THE APPLICATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 OUT OF 20 PIECES WERE FOUND WITH MISSING INFORMATION. PER COMPLAINT DETAILS RECEIVED: PART NUMBER: 30981; LOT: 1134389; P.O.: P145040; QUANTITY: 200; FAILURE MODE: MATERIAL WAS REJECTED DURING INCOMING INSPECTION DUE TO THE FOLLOWING CONDITION: 20 OUT OF 20 PIECES WERE FOUND WITH MISSING INFORMATION ACCORDING TO THE DRAWING.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 20 OUT OF 20 PIECES WERE FOUND WITH MISSING INFORMATION. PER COMPLAINT DETAILS RECEIVED: PART NUMBER: 30981 LOT: 1134389 P.O.: (B)(6) QUANTITY: 200 FAILURE MODE: MATERIAL WAS REJECTED DURING INCOMING INSPECTION DUE TO THE FOLLOWING CONDITION: 20 OUT OF 20 PIECES WERE FOUND WITH MISSING INFORMATION ACCORDING TO THE DRAWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167222 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1134389

    Patients

    Seq Age Sex Outcome Treatment
    1 Other