BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET

    MDR report key: 16583016 · Received March 21, 2023

    Report

    Report Number
    2243072-2023-00435
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 27, 2023
    Report Date
    June 13, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403230554
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 04-MAY-2023. B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE UBD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET LEAKED AFTER INJECTING RADIOACTIVE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONNECTOR CONSISTENTLY LEAKS AFTER THE TEAM MEMBERS INJECT RADIOACTIVE PHARMACEUTICALS. THIS CAUSES A RADIATION SAFETY PROBLEM AS THE RADIOACTIVE CONTAMINATION IS SPREAD TO THE PATIENT AS WELL AS THE EQUIPMENT. IT IS THEN NECESSARY FOR THE TEAM MEMBERS TO SPEND CONSIDERABLE TIME CLEANING UP THE CONTAMINATION" D1: MEDICAL DEVICE BRAND NAME: BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET D2: MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D4: UDI #: (B)(4). D4: MEDICAL DEVICE CATALOG #: MZ5302. D4: MEDICAL DEVICE LOT #: 22069346. D4: MEDICAL DEVICE LOT #: 22079040. D4: MEDICAL DEVICE EXPIRATION DATE: 23-JUN-2025. D4: MEDICAL DEVICE EXPIRATION DATE: 07-JUL-2025. G2: MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G.5. PMA / 510(K)#: K140831. H4: DEVICE MANUFACTURE DATE: 30-JUN-2022. H4: DEVICE MANUFACTURE DATE: 07-JUL-2022. H6: INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THERE IS MEDICATION RESIDUE ON THE MAXZERO WHEN OPENING/CLOSING, AND RETURNED 7 UNUSED SAMPLES. THERE WERE 6 SAMPLES OF LOT 22079040 AND ONE OF LOT 22069346. THE SAMPLES WERE TESTED, AND THE SMALL AMOUNT OF LIQUID REMAINING WAS CONFIRMED. THIS IS NOT AN ISSUE THAT WE SEE SOMETHING IS 'WRONG' WITH THE PRODUCT, BUT WE UNDERSTAND HOW IT IS A PROBLEM WHEN HANDLING CERTAIN MEDICATIONS. SALES WAS CONTACTED TO WORK WITH CUSTOMER ON OTHER OPTIONS. DEVICE HISTORY RECORD REVIEW FOR MODEL MZ5302 LOT NUMBER 22079040 WAS PERFORMED. . THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DEVICE HISTORY RECORD REVIEW FOR MODEL MZ5302 LOT NUMBER 22069346 WAS PERFORMED. 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

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. HAWAII, USA HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UBD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET LEAKED AFTER INJECTING RADIOACTIVE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONNECTOR CONSISTENTLY LEAKS AFTER THE TEAM MEMBERS INJECT RADIOACTIVE PHARMACEUTICALS. THIS CAUSES A RADIATION SAFETY PROBLEM AS THE RADIOACTIVE CONTAMINATION IS SPREAD TO THE PATIENT AS WELL AS THE EQUIPMENT. IT IS THEN NECESSARY FOR THE TEAM MEMBERS TO SPEND CONSIDERABLE TIME CLEANING UP THE CONTAMINATION".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD MAXZERO¿ MINIBORE PRESSURE RATED EXTENSION SET LEAKED AFTER INJECTING RADIOACTIVE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONNECTOR CONSISTENTLY LEAKS AFTER THE TEAM MEMBERS INJECT RADIOACTIVE PHARMACEUTICALS. THIS CAUSES A RADIATION SAFETY PROBLEM AS THE RADIOACTIVE CONTAMINATION IS SPREAD TO THE PATIENT AS WELL AS THE EQUIPMENT. IT IS THEN NECESSARY FOR THE TEAM MEMBERS TO SPEND CONSIDERABLE TIME CLEANING UP THE CONTAMINATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8086 BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MZ5302 22069346 10885403230554

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown