BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 10814432 · Received November 9, 2020

    Report

    Report Number
    3004932373-2020-00123
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    October 13, 2020
    Report Date
    December 31, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    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

    A SAMPLE AND PHOTOS ARE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF BOTH THE PHOTOS AND SAMPLE PRESENTED A HAIR INSIDE THE SEALED POUCH. THIS VERIFIES THE FAILURE MODE REPORTED. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) AND/ OR PREVENTIVE MEASURES DURING THE MANUFACTURING OF THE PRODUCT. PRODUCTION HISTORY RECORDS WERE REVIEWED FOR LOT 0128821 AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT. OUR RECORDS INDICATE THAT THE REVIEWED BATCH RECORD PASSED ALL THE IN-PROCESS INSPECTION. AN AWARENESS SESSION WAS CONDUCTED WITH PRODUCTION ASSOCIATES IN REGARDS THIS COMPLAINT. IN ADDITION, IMPROVEMENTS ARE BEING MADE FOR THE USE AND PRACTICES BY ASSOCIATES AS RELATED TO PERSONAL PROTECTIVE EQUIPMENT SUCH AS: A. DETERMINING BEST PRACTICES RELATED TO LONG HAIR ON ASSOCIATES AND B. DETERMINING BEST FIT GUIDELINES FOR LAB COATS. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    ONE OF THE STAFF FOUND HAIR INSIDE THE STERILE PACK OF 3ML CHLORAPREP. REF# 930415; LOT# 0128821; EXP. 04/2023. THE PACKAGE WAS NOT OPENED AND THE HAIR WAS INSIDE THE STERILE PACKAGING.

    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

    DATE RECEIVED FOR INTAKE: 14-OCT-2020. MATERIAL NO: 930415; BATCH NO: 0128821. IT WAS REPORTED THAT A STAFF MEMBER, ON (B)(6) 2020, DISCOVERED FOREIGN MATTER - HAIR (FM - HAIR) INSIDE OF AN UNOPENED, STERILE PACKAGE. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: ONE OF THE STAFF FOUND HAIR INSIDE THE STERILE PACK OF 3ML CHLORA-PREP. REF# (B)(4); LOT# 0128821; EXP. 04/2023. THE PACKAGE WAS NOT OPENED, AND THE HAIR WAS INSIDE THE STERILE PACKAGING. COMPLAINT RATIONALE: BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX 1 - COMPLAINT DETERMINATION TREE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272400 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 0128821

    Patients

    Seq Age Sex Outcome Treatment
    1 Other