BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    MDR report key: 20571515 · Received October 30, 2024

    Report

    Report Number
    9616066-2024-01579
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 4, 2024
    Report Date
    January 27, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WAS A SEPARATION. TWO SAMPLES MODEL MZ9266, LOT 24049084, ONE USED AND ONE UNUSED WAS RETURNED FOR INVESTIGATION. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. THE USED SET TUBING WITH THE WHITE CLAMP WAS SEPARATED FROM THE MAXZERO. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED. THE TUBING WAS MEASURED AND FOUND WITHIN SPEC. THE CUSTOMER COMPLAINT WAS REPLICATED AND A QUALITY NOTIFICATION WAS SENT TO THE MANUFACTURER. A DEVICE HISTORY RECORD REVIEW FOR MODEL MZ9266 LOT NUMBER 24049084 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 03APR2024. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MATERIAL# MZ9266 BATCH# 24049084. IT WAS REPORTED BY CUSTOMER THAT THE TRI-FUSE CONNECTORS & ASSOCIATED IV LINES, THIS RN FOUND THAT THE MALE ADAPTER / CAP TO THE 'WHITE' LUMEN OF THE TRI-FUSE WAS LOOSE AT THE BASE OF THE CONNECTOR TO THE LINE. THE IV LINE WOULD SLIDE IN AND OUT OF THE BASE OF THE MALE ADAPTER; THUS, ALLOWING THE INFUSING MED TO LEAK AT THIS SITE AND NOT INFUSE CORRECTLY. THE TRI-FUSE HAS BE SEQUESTERED ALONG WITH THIS KKS EVENT NUMBER. VERBATIM: (B)(6) 2024 12:39 PM BY RISK,RDE. DURING BEDSIDE SHIFT CHANGE REPORT; THIS RN TRACED ALL IV LINES AND NOTICED SOME MOISTURE ON LINES AND A TOWEL BENEATH IV LINES. DAY SHIFT RN NOTIFIED NIGHT SHIFT RN OF FINDINGS, BUT NO LEAK / SOURCE COULD BE DETECTED. A DRY CLOTH WAS PLACED BELOW ALL IV LINES AND LINES WERE WIPPED DRY. RN TRACED LINES AGAIN EACH HOUR, LOCATING VERY SLIGHT MOISTURE AT ONE SPOT. AT 1100 THE TOWEL BELOW THIS ISOLATED SPOT WAS WET. UPON INVESTIGATING THE TRI-FUSE CONNECTORS & ASSOCIATED IV LINES, THIS RN FOUND THAT THE MALE ADAPTER / CAP TO THE 'WHITE' LUMEN OF THE TRI-FUSE WAS LOOSE AT THE BASE OF THE CONNECTOR TO THE LINE. THE IV LINE WOULD SLIDE IN AND OUT OF THE BASE OF THE MALE ADAPTER; THUS ALLOWING THE INFUSING MED TO LEAK AT THIS SITE AND NOT INFUSE CORRECTLY. THE TRI-FUSE HAS BE SEQUESTERED ALONG WITH THIS KKS EVENT NUMBER. ADDITIONAL INFORMATION 10/04/2024: THE REFERENCE NUMBER ON THIS COMMUNICATION SAYS MZ9226 AND IT HAS BEEN RETURNED. I STILL HAVE MZ9266 TRIFUSE AND HAVE NOT RECEIVED THE RETURN LABEL OR PIR FOR IT. DO I DISCARD? 1. COULD YOU PLEASE DESCRIBE IN DETAIL THE ISSUES YOU HAVE ENCOUNTERED WITH MATERIAL NO. MZ9266 TRIFUSE? 2. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. 3. PLEASE SHARE THE LOT NUMBER. 4. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. 5. PLEASE WAIT FOR THREE BUSINESS DAYS AND LET US KNOW ONCE YOU RECEIVED THE SHIPPING LABEL AND THE SAMPLE HAS BEEN SHIPPED FROM YOUR END? RESPONSE RECEIVED ON OCT 9/ 2024. I HAVE NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS LOOSE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM DURING BEDSIDE SHIFT CHANGE REPORT; THIS RN TRACED ALL IV LINES AND NOTICED SOME MOISTURE ON LINES AND A TOWEL BENEATH IV LINES. DAY SHIFT RN NOTIFIED NIGHT SHIFT RN OF FINDINGS, BUT NO LEAK / SOURCE COULD BE DETECTED. A DRY CLOTH WAS PLACED BELOW ALL IV LINES AND LINES WERE WIPPED DRY. RN TRACED LINES AGAIN EACH HOUR, LOCATING VERY SLIGHT MOISTURE AT ONE SPOT. AT 1100 THE TOWEL BELOW THIS ISOLATED SPOT WAS WET. UPON INVESTIGATING THE TRI-FUSE CONNECTORS & ASSOCIATED IV LINES, THIS RN FOUND THAT THE MALE ADAPTER / CAP TO THE 'WHITE' LUMEN OF THE TRI-FUSE WAS LOOSE AT THE BASE OF THE CONNECTOR TO THE LINE. THE IV LINE WOULD SLIDE IN AND OUT OF THE BASE OF THE MALE ADAPTER; THUS ALLOWING THE INFUSING MED TO LEAK AT THIS SITE AND NOT INFUSE CORRECTLY. THE TRI-FUSE HAS BE SEQUESTERED ALONG WITH THIS KKS EVENT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929693 BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown