BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 16464221 · Received March 1, 2023

    Report

    Report Number
    1710034-2023-00164
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    February 9, 2023
    Report Date
    March 30, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT: 01MAR2023: (B)(4). INITIAL MDR. A FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(6).

    Additional Manufacturer Narrative · 0

    28 PHOTOS WERE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF ALL PHOTOS IDENTIFIED MOLD GROWTH ON THE OUTER BOXES OF THE PALLET. THIS VERIFIED THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE DEFINED AT THIS TIME. QUERY OF ALL COMPLAINTS 2017 TO 24 FEB 2023 FOR SKU 372053 WAS PERFORMED. ELEVEN TOTAL COMPLAINTS WERE INVESTIGATED DURING THE PERIOD. NO RELATED COMPLAINTS WERE IDENTIFIED REGARDING THIS ISSUE, INCLUDING MOLD, CONTAMINATION, OR FOREIGN MATTER COMPLAINTS. THE QUERY PERFORMED DID NOT IDENTIFY ANY SPECIFIC COMPLAINTS FOR LOT 2229737. ENVIRONMENTAL MONITORING DATA WAS REVIEWED FOR THE AREA DURING THE MONTH OF PRODUCTION (AUGUST 2022) AND THE PRECEDING MONTH (JULY 2022) FOR THE SCRUB ASSEMBLY AND SCRUB MOLDING AREAS. ALL DATA IS WITHIN SPECIFICATION AND NO MOLD OR YEAST WAS IDENTIFIED FROM ENVIRONMENTAL MONITORING. 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. THE IMPACT TO ALL OTHER PRODUCT IS CONSIDERED LOW. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MOLD FOUND ON PRODUCT CASE CARTON FOR SKU 372053, LOT 2229737, FROM MULTIPLE PALLETS IN RDC WAREHOUSE. DISCOVERED DURING OUTBOUND PICKING BY PICKER.

    Description of Event or Problem · 0

    MOLD FOUND ON PRODUCT CASE CARTON FOR SKU 372053, LOT 2229737, FROM MULTIPLE PALLETS IN RDC WAREHOUSE. ADDITIONAL INFORMATION RECEIVED 05-MAR-2023 ¿ FROM THE 8D REPORT, THERE IS A DISCREPANCY BETWEEN DATES. WHEN WAS THE ISSUE DISCOVERED? ATTACHED AMENDED 8D REPORT. ¿ WAS THE ISSUE FOUND ON THE OUTSIDE OF THE SHIPPERS ONLY, OR WAS IT ALSO FOUND IN THE INTERIOR OF THE SHIPPER, ON THE PRODUCT DISPENSER BOXES, OR THE INDIVIDUAL UNITS? INSPECTION PERFORMED IN CASE CARTON LEVEL ONLY. ¿ WAS THE CONTAMINATION CONFIRMED TO BE MOLD? YES ¿ IS THE PRODUCT PHYSICALLY DESTROYED? PRODUCT HAS BEEN PHYSICALLY SCRAPPED ON 20 FEB 2023. ADDITIONAL INFORMATION RECEIVED 05-MAR-2023 I HAVE RESPONDED TO THIS QUESTION VIA ANOTHER EMAIL THREAD. PLEASE REFER TO THE ATTACHED EMAIL FOR FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921582 BD E-Z SCRUB BD E-Z SCRUB GEC BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2229737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other