BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 22982681 · Received September 5, 2025

    Report

    Report Number
    9616066-2025-02679
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 11, 2025
    Report Date
    August 14, 2025
    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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE OF EVENT IS UNKNOWN; BD AWARENESS DATE USED. DEVICE EVALUATION: A MZ1000 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION OF (B)(4); HOWEVER, THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 25025415. THE FEEDBACK PROVIDED BY THE CUSTOMER STATES THAT, "NEEDLESS CONNECTOR (NC) DID NOT ALLOW FREE FLOW OF SALINE WHEN CONNECTED TO IV LINE. UPON FURTHER INVESTIGATION AFTER REMOVING NC FROM LINE, NC REQUIRED FORCEFUL FLUSH." FURTHER INFORMATION FROM THE CUSTOMER HAS STATED THAT COMPLETELY BLOCKAGE WAS NOTICED DURING PRIMING OF NORMAL SALINE (NIL MEDICATION) UNTIL FORCEFUL FLUSH. THE CONNECTING PRODUCTS USED WERE VOLUMAT LINE (FRESENIUS KABI REF: VLST22), BD MAX ZERO AND STOPCOCK (BD CONNECTA REF: 394995) AND THE CONNECTION WAS LUER LOCK CONNECTION. NO VISIBLE DAMAGES WERE OBSERVED WITH THE PRODUCT AND THERE IS NO PATIENT IMPACT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 25025415 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE TO EXAMINE IT HAS NOT BEEN POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE; HOWEVER, A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE PRODUCT MZ1000 IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXZERO NEEDLELESS CONNECTOR HAD AN OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLESS CONNECTOR (NC) DID NOT ALLOW FREE FLOW OF SALINE WHEN CONNECTED TO IV LINE. UPON FURTHER INVESTIGATION AFTER REMOVING NC FROM LINE, NC REQUIRED FORCEFUL FLUSH IN ORDER TO ACHIEVE PATENCY. 1 PER WEEK NOTED TO HAVE THIS ISSUE FOR THE PAST 2 MONTHS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE CONFIRM WHEN WAS THE ISSUE IDENTIFIED? DURING PRIMING OR INFUSION? DURING PRIMING PLEASE CONFIRM WHAT MEDICATION WAS BEING ADMINISTERED DURING THE EVENT? NORMAL SALINE (NIL MEDICATION) PLEASE CONFIRM THE MAKE AND MODEL OF THE CONNECTING PRODUCTS? VOLUMAT LINE (FRESENIUS KABI REF: VLST22), BD MAX ZERO, STOPCOCK (BD CONNECTA REF: 394995) PLEASE CONFIRM IF THERE ARE ANY VISIBLE DEFECTS TO THE DEVICE I.E., CRACKS, FLASHES, KINKS? NIL VISIBLE PLEASE CONFIRM IF THE CONNECTING PRODUCT HAS A LUER SLIP OR LUER LOCK CONNECTION? LUER LOCK PLEASE CONFIRM WHETHER THE FLOW WAS COMPLETELY OR PARTIALLY BLOCKED? FLOW WAS COMPLETELY BLOCKED UNTIL FORCEFUL FLUSH PLEASE CONFIRM IF THERE IS ANY PATIENT IMPACT? NIL. PLEASE CONFIRM HOW MANY PRODUCTS ARE AFFECTED? 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237348 BD MAXZERO NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 25025415 10885403224782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown