BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DURASAFE¿ TRAY

    MDR report key: 15660200 · Received October 24, 2022

    Report

    Report Number
    3014704491-2022-00508
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    December 7, 2021
    Report Date
    November 28, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    CAZ
    UDI-DI
    00382904016227
    PMA / PMN Number
    K012584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?: YES RETURNED TO MANUFACTURER ON: (B)(6)2022 INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1070521. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, A SAMPLE WAS RETURNED TO OUR FACILITY TO AID IN OUR INVESTIGATION. OUR ENGINEERS WERE ABLE TO IDENTIFY WRINKLES IN THE WHITE DRAPE. THIS IS A COSMETIC ISSUE THAT IS CAUSED BY COMPRESSION DURING TRANSPORTATION AFTER MANUFACTURE. OUR ENGINEERS HAVE ALSO REVIEWED AND EVALUATED THE KIT FOR EXTRANEOUS MATERIAL, BUT WERE UNABLE TO IDENTIFY ANY INSTANCES OF THE REPORTED FOREIGN MATTER. THE ISSUE COULD NOT BE CONFIRMED. UNFORTUNATELY, WITHOUT THE ABILITY OBSERVE THE REPORTED NON-CONFORMANCE OUR ENGINEERS COULD NOT DETERMINE A ROOT CAUSE FOR THIS EVENT. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE#: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING OF 2 BD DURASAFE¿ TRAYS WAS BROKEN, COMPROMISING THEIR STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PACKAGE WAS BROKEN."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING OF 2 BD DURASAFE¿ TRAYS WAS BROKEN, COMPROMISING THEIR STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PACKAGE WAS BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028894 BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT CAZ BD (SUZHOU) 1070521 00382904016227

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown