BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP

    MDR report key: 10932772 · Received December 2, 2020

    Report

    Report Number
    3004932373-2020-00139
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 2, 2020
    Report Date
    January 27, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS WERE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF THE PHOTOS VERIFIED THE FAILURE MODE OF FOREIGN MATTER (HAIR). THE HAIR ORIGINATES FROM AN OPERATOR. THE PROCESS HAS CERTAIN MANUAL PROCESSES THAT MAY RESULT IN HAIR ON THE PRODUCT. THE PROCEDURES/PROCESS INCLUDES PREVENTIVE MEASURES FOR HAIR IN PRODUCT. IT IS POSSIBLE FOR ASSOCIATES TO ACCIDENTALLY SHED HAIR ONTO PRODUCT AS THEY ARE LOADING COMPONENTS INTO THEIR CORRESPONDING CONTAINERS/PACKAGES, ALTHOUGH ASSOCIATES WEAR HAIR NETS, GLOVES, SAFETY GLASSES, AND HEAD COVERS; IF WORN IMPROPERLY IT COULD LEAD TO THE REPORTED ISSUE. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) AND/OR PREVENTIVE MEASURES DURING THE MANUFACTURING OF THE PRODUCT. PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 0132378 AND NO NON-CONFORMANCE WAS 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.: 930800 BATCH NO.: 0132378. IT WAS REPORTED THAT A HAIR WAS FOUND IN THE PRODUCT. PER EMAIL: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE, RESPOND ACCORDINGLY WITH THE RMA NUMBER, IF NECESSARY, AND THE DISPOSITION OF THE CUSTOMER'S CONCERN. PLEASE CONTACT THE CUSTOMER AND CC ME ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE: (B)(4). ITEM: 930800. QUANTITY AFFECTED: 1 CASE. LOT NUMBER: 0132378. PO #: (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE CLIENT HAS STATED THAT THEY HAVE OPEN SERVAL OF THESE AND THERE WAS HAIR IN THE PRODUCT WHILE OPENING. HERE ARE PHOTOS. CUSTOMER DISPOSITION REQUEST: CREDIT.

    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

    MATERIAL NO.: 930800; BATCH NO.: 0132378. IT WAS REPORTED THAT A HAIR WAS FOUND IN THE PRODUCT. PER EMAIL: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE, RESPOND ACCORDINGLY WITH THE RMA NUMBER, IF NECESSARY, AND THE DISPOSITION OF THE CUSTOMER'S CONCERN. PLEASE CONTACT THE CUSTOMER AND CC ME ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE: (B)(4); ITEM: 930800; QUANTITY AFFECTED: 1 CASE; LOT NUMBER: 0132378; PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE CLIENT HAS STATED THAT THEY HAVE OPEN SERVAL OF THESE, AND THERE WAS HAIR IN THE PRODUCT WHILE OPENING. HERE ARE PHOTOS. CUSTOMER DISPOSITION REQUEST: CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401255 CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 0132378

    Patients

    Seq Age Sex Outcome Treatment
    1 Other