BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 18347148 · Received December 18, 2023

    Report

    Report Number
    9616066-2023-02420
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 16, 2023
    Report Date
    January 12, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403224782
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE MZ1000 SAMPLE WAS RETURNED WITHOUT PACKAGING FOR INVESTIGATION. THE CUSTOMER REPORTED THAT THEY IDENTIFIED CRACKING ON THE MAXZERO, HOWEVER NO FURTHER INFORMATION REGARDING THE USE AND SETUP OF THE MAXZERO, INCLUDING THE LOT WAS PROVIDED. A VISUAL INSPECTION OF THE RETURNED SAMPLE CONFIRMED THE CUSTOMER'S EXPERIENCE AS A HAIRLINE CRACK WAS IDENTIFIED ON THE FEMALE LUER ADAPTOR OF THE MAXZERO. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. IN THIS INSTANCE A LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED IN THIS INSTANCE, HOWEVER PREVIOUS INVESTIGATIONS HAVE CONFIRMED SIMILAR DAMAGE CAN BE CAUSED OR CONTRIBUTED TO BY A COMBINATION OF DIFFERENT FACTORS, INCLUDING PROLONGED USE OF SUBSTANCES THAT ARE AGGRESSIVE TO PLASTICS, OVER-TORQUE OF THE COMPONENT DURING CONNECTION WITH THE MALE LUER, OR USE OF A MALE LUER THAT IS NOT COMPLIANT TO ISO STANDARDS. BASED ON THE INFORMATION AVAILABLE IT HAS NOT BEEN POSSIBLE TO DETERMINE WHICH OF THESE FACTORS WERE KEY CONTRIBUTORS TO THE CUSTOMER'S EXPERIENCE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE MZ1000 PRODUCT IN THE PAST 12 MONTHS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD - MAXZERO NEEDLELESS CONNECTOR WAS DAMAGED/ CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: CRACKING OCCURRED. NF, (B)(6) 2023 : PLEASE RETURN THE AFFECTED PRODUCT(S) (WITH ITS ORIGINAL PACKAGING IF POSSIBLE) FOR INVESTIGATION? SAMPLE WILL BE SENT FOR INVESTIGATION. IF IT IS NOT POSSIBLE TO RETURN THE AFFECTED PRODUCT, PLEASE PROVIDE DETAILED PHOTOGRAPHS OF THE PRODUCT(S) AND THE DAMAGED AREA(S)? PHOTO ATTACHED IN TW. PLEASE CONFIRM THE NUMBER OF PRODUCTS AFFECTED? 1 PRODUCT. PLEASE CONFIRM THE LOT NUMBER(S)? IF NOT, PLEASE PROVIDE THE LASER ID THAT CAN BE FOUND ON THE MAXZERO'S BODY? UNKNOWN. PLEASE CONFIRM WHAT SUBSTANCE WAS BEING INFUSED DURING THE TIME OF THE EVENT? WE HAVE HEARD THAT THE PATIENT WAS FLUSHED WITH RAW FOOD. PLEASE CONFIRM WHEN THE FAULT WAS IDENTIFIED DURING PRIMING OR DURING INFUSION? IF DURING INFUSION, HOW LONG INTO THE INFUSION? DURING INFUSION. PLEASE CONFIRM THE EXACT LOCATION OF THE CRACK? NEEDLELESS CONNECTOR. SEE THE PHOTO. PLEASE CONFIRM IF THE DAMAGE LED TO LEAKAGE? DAMAGE IS LEADING TO LEAKAGE. PLEASE CONFIRM IF THE PRODUCT WAS DISINFECTOR PRIOR USE? IF SO, WHAT SUBSTANCE WAS USED? AL COTTON USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982065 BD MAXZERO NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 10885403224782

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown