BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 11108243 · Received January 4, 2021

    Report

    Report Number
    1710034-2020-00834
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    December 2, 2020
    Report Date
    April 12, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    LRJ
    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

    PHOTOS ARE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF THE PHOTO SHOWS A BREAK IN THE PACKAGE SEAL. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BASED ON THE PHOTOS, IT IS LIKELY A NAIL PICK WAS MISPLACED AND WAS IN THE SEAL PATH, CAUSING AN INADEQUATE SEAL. FROM THE PRODUCTION RECORD BATCH REVIEW OF BATCH/LOT 0147549 AND RETAIN REVIEW, IT IS UNCLEAR HOW THE THE BREACHED SEAL OCCURRED AND SHOWS NO FINDINGS, DEVIATIONS, OR DISCREPANCIES THAT WOULD ATTRIBUTE TO THIS ISSUE . ALL CHALLENGES FOR VISION SYSTEM AND IPQC FOR SEAL INTEGRITY PASSED PER BATCH RECORD AND INSPECTION OF RETAINS DID NOT SHOW THIS DEFECT. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IN THE BRUSH BOX WITH REFERENCE (B)(4), TWO DAMAGED PARTS CAME OUT. WE REALIZED THE DAMAGE WHEN WE WERE LABELING THE MATERIAL .1 ONE IS BROKEN. 2. THE OTHER IS MANUFACTURING DAMAGED. ** ADD.. INF.: THE CUSTOMER REPORTS THAT MANUFACTURING DAMAGE MEANS THAT THE PACKAGE IS BROKEN. *** ** ADD. INF: DEC8, 2020: THE CUSTOMER RESPOND ¿THE PRODUCT WAS ACTIVATED, BEFORE USING IT ALREADY CAME ACTIVATED IN THE ORIGINAL BOX¿.

    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

    IN THE BRUSH BOX WITH REFERENCE 371073, TWO DAMAGED PARTS CAME OUT. WE REALIZED THE DAMAGE WHEN WE WERE LABELING THE MATERIAL ONE IS BROKEN, THE OTHER IS MANUFACTURING DAMAGED. INF. ADDITIONAL: THE CUSTOMER REPORTS THAT MANUFACTURING DAMAGE MEANS THAT THE PACKAGE IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4149 BD E-Z SCRUB CHLORAHEXIDINE GLUCONATE SOLUTION LRJ CAREFUSION, INC 0147549

    Patients

    Seq Age Sex Outcome Treatment
    1 Other