BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO¿ EXTENSION SET

    MDR report key: 14651673 · Received June 10, 2022

    Report

    Report Number
    2243072-2022-00789
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 21, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403230608
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. DEVICE EXPIRATION DATE: UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD MAXZERO¿ EXTENSION SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS BLOOD REFLUX AFTER THE ADMINISTRATION OF DRUGS BY SIMPLE DESCENT, AND DOUBTS AROSE REGARDING THE CHANGE OF THE NEEDLE-FREE CONNECTORS, WHICH ARE ALREADY INCLUDED IN THE EXTENSION. D.1. MEDICAL DEVICE BRAND NAME: BD MAXZERO¿ EXTENSION SET. D.2. MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D.4. MEDICAL DEVICE CATALOG #: MZ5307. D.4. MEDICAL DEVICE LOT #: 21096362. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-09-29. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G.5. PMA/510(K)#: K140831. H.4. DEVICE MANUFACTURE DATE: 2021-09-28. H.6 INVESTIGATION SUMMARY: A MZ5307 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER, THE CUSTOMER INDICATED THE COMPLAINT SAMPLE WAS FROM LOT 21096362. THE FEEDBACK PROVIDED BY THE CUSTOMER INDICATES THE BD MAXZERO EXTENDERS WERE TRIALLED IN THE HOSPITAL BY THE NURSES AS A REPLACEMENT FOR THE CURRENTLY USED KDL EXTENDERS, DURING THE TRIAL THE CUSTOMER CONFIRMS THAT THEY EXPERIENCED BACKFLOW OF BLOOD AFTER THE ADMINISTRATION OF DRUGS. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 21096362 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS A SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. PLEASE NOTE THAT MAXZERO VALVES ARE NOT BACK CHECK VALVES AND ARE NOT DESIGNED TO PREVENT BACK FLOW WHEN CONNECTED TO ANOTHER INFUSION SET. FURTHERMORE AS STATED IN THE DIRECTIONS FOR USE OF THE MAXZERO VALVE "FLUSH THE MAXZERO AFTER EACH USE WITH NORMAL SALINE OR IN ACCORDANCE WITH FACILITY PROTOCOL. FAILURE TO PROPERLY PRIME THE DEVICE CAN RESULT IN REFLUX." A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED FEEDBACK WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE MZ5307 PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD MAXZERO EXTENSION SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS BLOOD REFLUX AFTER THE ADMINISTRATION OF DRUGS BY SIMPLE DESCENT, AND DOUBTS AROSE REGARDING THE CHANGE OF THE NEEDLE-FREE CONNECTORS, WHICH ARE ALREADY INCLUDED IN THE EXTENSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXZERO¿ EXTENSION SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS BLOOD REFLUX AFTER THE ADMINISTRATION OF DRUGS BY SIMPLE DESCENT, AND DOUBTS AROSE REGARDING THE CHANGE OF THE NEEDLE-FREE CONNECTORS, WHICH ARE ALREADY INCLUDED IN THE EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056457 BD MAXZERO¿ EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 21096362 10885403230608

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown