BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP SKIN SCRUB TRAY

    MDR report key: 12778862 · Received November 9, 2021

    Report

    Report Number
    1423507-2021-00050
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 13, 2021
    Report Date
    November 9, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    OJU
    UDI-DI
    10885403184475
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS ARE AVAILABLE FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THE DEVICE HISTORY RECORD FOR THE PART NUMBER 4468 WITH LOT NUMBER 0004184317 AND UDI CODE (B)(4) WAS REVIEWED IN ORDER TO DETECT ANY ISSUE RELATED WITH THE REPORTED DEFECT DURING ITS MANUFACTURING. THE COMPLETE LOT WAS MANUFACTURED INSPECTED AND RELEASED ON 11MAY2021 PER OUR INTERNAL PROCEDURES AND NO ISSUES WERE FOUND. PERSONNEL, PROCESS, MATERIAL, EQUIPMENT, ENVIRONMENT AND DESIGN DID NOT CONTRIBUTE WITH THE DEFECT REPORTED BY THE CUSTOMER. NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. MANUFACTURING PERSONNEL WERE NOTIFIED ABOUT THE COMPLAINT. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PER CLINICAL DEPARTMENT, THERE IS A HAIR INSIDE THE TRAY. VERBATIM: BY WAY OF THIS EMAIL, WE WOULD LIKE TO FILE THE FOLLOWING PRODUCT COMPLAINT: ITEM: TRAY PREP SKIN WET SCRUB CARE. MANUFACTURER CATALOG #: 4468. LOT #: 0004184317. QUANTITY OF DEFECTIVE PRODUCT: 1 EACH. ISSUES: PER CLINICAL DEPARTMENT, THERE IS A HAIR INSIDE THE TRAY. PLEASE KINDLY FORWARD THIS PRODUCT COMPLAINT TO YOUR COMPANY QA DEPARTMENT APPROPRIATELY. IN ADDITION, PLEASE PROVIDE US WITH INVESTIGATION RESULT REPORT (ONCE IT¿S AVAILABLE).

    Description of Event or Problem · 0

    IT WAS REPORTED PER CLINICAL DEPARTMENT, THERE IS A HAIR INSIDE THE TRAY. VERBATIM: BY WAY OF THIS EMAIL, WE WOULD LIKE TO FILE THE FOLLOWING PRODUCT COMPLAINT: ITEM: TRAY PREP SKIN WET SCRUB CARE, MANUFACTURER CATALOG #: 4468, LOT #: 0004184317, QUANTITY OF DEFECTIVE PRODUCT: 1 EACH. ISSUES: PER CLINICAL DEPARTMENT, THERE IS A HAIR INSIDE THE TRAY. PLEASE KINDLY FORWARD THIS PRODUCT COMPLAINT TO YOUR COMPANY QA DEPARTMENT APPROPRIATELY. IN ADDITION, PLEASE PROVIDE US WITH INVESTIGATION RESULT REPORT (ONCE IT¿S AVAILABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676866 IP SKIN SCRUB TRAY SKIN SCRUB TRAY OJU CAREFUSION, INC 4468 0004184317 10885403184475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other