BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 17037881 · Received June 1, 2023

    Report

    Report Number
    1710034-2023-00597
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    May 5, 2023
    Report Date
    July 27, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL EXAMINATION OF THE PHOTO SHOWS APPARENT MOLD ON THE OUTER CARTON OF THE PRODUCTS. THIS VERIFIED THE REPORTED ISSUE. THE ROOT CAUSE COULD NOT BE DEFINED AT THIS TIME WITHOUT THE SAMPLES AVAILABLE TO EXAMINE. A PROBABLE ROOT CAUSE COULD BE THE TEMPERATURE AND HUMIDITY OF THE AREA THE PRODUCT WAS SHIPPED TO. THE SHIPMENT IS DONE VIA BOAT IN A METAL SHIPPING CONTAINER. THERE ARE NO ENVIRONMENTAL CONTROLS IN THE CONTAINER TO PREVENT AGAINST CONDENSATION BUILD UP ON PRODUCT FROM THE INCREASED HUMIDITY OF THE AREA. A PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCHES/LOTS 2130571, 2228844, 2258916 AND NO FINDINGS WERE RELATED TO THE COMPLAINT. A VISUAL INSPECTION OF 30 RETAINED UNITS WAS COMPLETED. NO MOLD/ FOREIGN FOUND ON PACKAGE UNITS OR DISPENSER. THE RETAINED UNITS ARE ACCEPTABLE. A QUERY OF ALL COMPLAINTS FROM 2017 TO 05 MAY 2023 FOR SKU 372053 WAS PERFORMED. NINE TOTAL COMPLAINTS WERE INVESTIGATED DURING THE PERIOD. COMPLAINT PR (B)(4) WAS IDENTIFIED FOR MOLD ON THE OUTSIDE OF SHIPPERS AT THE SINGAPORE DC. ALL IMPACTED PRODUCT WAS CONTAINED AND DESTROYED ON FEBRUARY 20,2023 AT THE SINGAPORE RDC WAREHOUSE. THE COMPLAINT, QN AND ENVIRONMENTAL MONITORING DATA SUGGEST THAT THE MOLD WAS LIMITED TO THE SHIPPERS IDENTIFIED IN THE SINGAPORE WAREHOUSE. A CORRECTIVE ACTION WAS IMPLEMENTED REQUIRING THE ASSOCIATES AT THE REDLANDS DC TO LINE THE SHIPPING CONTAINERS WITH DESICCANT PACKS BEFORE LOADING PRODUCT. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    PR 7920992 INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IMDRF ANNEX E CODE HEALTH EFFECT ¿ CLINICAL CODE: E2403 IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: A18.

    Description of Event or Problem · 0

    VERBATIM: ACROSS MULTIPLE DELIVERIES PRODUCT 372053 HAS BEEN DELIVERED WITH MOULD ON THE PARTS OF THE BOXES TURNED TOWARDS THE INSIDE OF THE PALLET. THE MOULDY BOXES HAVE NOT BEEN IDENTIFIED DURING RECEIVAL PROCESS AS ITS NOT VISIBLE FROM THE OUTSIDE OF THE PALLET, WHEN THE PALLETS ARE BROKEN APART FOR DELIVERIES THE MOULD CAN BE SEEN. THIS NON CONFORMANCE IS AGAINST INCOMING PROCEDURE. PRODUCTS WERE DISTRIBUTED FROM THE SINGAPORE DISTRIBUTION CENTRE AND MANUFACTURED IN SANDY. ADDITIONAL INFORMATION RECEIVED ON 23-MAY-2023. 1. IS THERE ANY PATIENT INVOLVEMENT? IF YES, WHAT WAS THE PATIENT OUTCOME? NO PATIENT INVOLVEMENT 2. WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY? NO 3. IS SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE FACILITY ADDRESS FOR SAMPLE RETURN LABEL. NO SAMPLE AVAILABLE FOR INVESTIGATION 4. IF SAMPLE IS AVAILABLE, PLEASE PROVIDE THE QUANTITY TO BE RETURN AS IT WAS NOTED THAT THERE WERE HUGE NUMBER OF PRODUCTS AFFECTED.

    Description of Event or Problem · 0

    MATERIAL #: 372053 BATCH #: 2130571, 2228844, 2258916. IT WAS REPORTED BY THE CUSTOMER THAT PRODUCT BEEN DELIVERED WITH MOULD ON THE PARTS OF THE BOXES TURNED TOWARDS THE INSIDE OF THE PALLET. VERBATIM: ACROSS MULTIPLE DELIVERIES PRODUCT 372053 HAS BEEN DELIVERED WITH MOULD ON THE PARTS OF THE BOXES TURNED TOWARDS THE INSIDE OF THE PALLET. THE MOULDY BOXES HAVE NOT BEEN IDENTIFIED DURING RECEIVAL PROCESS AS ITS NOT VISIBLE FROM THE OUTSIDE OF THE PALLET, WHEN THE PALLETS ARE BROKEN APART FOR DELIVERIES THE MOULD CAN BE SEEN. THIS NON CONFORMANCE IS AGAINST INCOMING PROCEDURE. PRODUCTS WERE DISTRIBUTED FROM THE (B)(4) AND MANUFACTURED IN SANDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830506 BD E-Z SCRUB BD E-Z SCRUB GEC BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2258916

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other