BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 11749290 · Received April 29, 2021

    Report

    Report Number
    1710034-2021-00349
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    January 13, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BECTON DICKINSON SANDY
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). SAMPLES AND PHOTOS WERE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION WAS DONE ON THE RETURNED 8 SAMPLES AND THE DISPENSER BOX. THE 8 SAMPLES WERE REVIEWED FOR SEAL BREACH AND ALL 8 SAMPLE SEALS APPEAR TO BE INTACT. THE DISPENSER BOX EXAMINED FOR SOAP RESIDUE AND NOTHING WAS FOUND. THE BAG THAT THE SAMPLES ARRIVED DID HAVE SMALL AMOUNTS OF SOAP RESIDUE. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE. THE REVIEW OF THE RISK MANAGEMENT DOCUMENT SHOWS THAT THIS RISK IS ACCEPTABLE WITH POTENTIAL MODES OF FAILURE BEING LEAKING AND CUSTOMER DISSATISFACTION AND BOTH HAVE A LOW SEVERITY RATING. PRODUCTION RECORD REVIEW WAS COMPLETED WITH BATCH/LOT 0204987 AND NO DEVIATIONS/DISCREPANCIES THAT WOULD CAUSE OR CONTRIBUTE TO THIS ISSUE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED 5 PACKAGE WERE OPENED AND UNUSABLE. IT WAS CLARIFIED THAT THE FOAM CAME OUT OF THE SIDE OF THE PRODUCT PRIOR TO USE. 5 PACKAGES WERE OPENED AND UNUSABLE. CUSTOMER WOULD LIKE TO RECEIVE CREDIT OR REPLACEMENT. PER PHONE CALL: 5 FOAM CAME OUT OF THE SIDE OF THEM WHEN PULLED OUT OF THE PACKAGE. UNUSED SAMPLES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647155 BD E-Z SCRUB CHLORHEXIDINE GLUCONATE GEC BECTON DICKINSON SANDY 0204987

    Patients

    Seq Age Sex Outcome Treatment
    1 Other