BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO¿ EXTENSION SET

    MDR report key: 15480290 · Received September 24, 2022

    Report

    Report Number
    9616066-2022-01409
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 31, 2022
    Report Date
    October 17, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 26-SEP-2022 . H6: INVESTIGATION SUMMARY TWO SAMPLES WERE SUBMITTED OF MATERIAL NUMBER MZX5306, LOT NUMBER 22029806. THE CUSTOMER COMPLAINT OF ADAPTOR CONNECTOR / DAMAGED COULD NOT BE VERIFIED. INSPECTION OF THE SAMPLES SUBMITTED DID NOT SHOW ANY INDICATION OF DAMAGE TO THE COMPONENTS OF THE ASSEMBLY. IN ADDITION TO THE INSPECTION, COMPARISON TO THE COMPONENT DESIGN DRAWINGS AND THE BUILD OF MATERIALS FOR THE FULL ASSEMBLY VERIFIED THAT THE CONSTRUCTION OF THE EXTENSION SET WAS CORRECT. THE SAMPLES WERE PRIMED AND CONNECTED TO A SYRINGE FILLED WITH WATER TO THE MAXZERO CONNECTOR OF THE EXTENSION SET. THE MALE LUER CONNECTION WAS ALSO CAPPED IN ORDER TO KEEP PRESSURE IN THE EXTENSION SET ASSEMBLY. STEADY PRESSURE WAS APPLIED TO THE SYRINGE IN ORDER TO INDUCE LEAKAGE FROM THE EXTENSION SET. THERE WERE NO INDICATIONS OF LEAKAGE, AIR-IN-LINE, OR OCCLUSIONS NOTICED AT ANY POINT DURING THE TESTING OF THE EXTENSION SET. ADDITIONALLY, THE CONNECTION WAS MANIPULATED TO SEE IF THE CAP ON THE MALE LUER CONNECTOR OR THE CONNECTION TO THE MAXZERO CONNECTOR WOULD LOOSEN. THERE WERE NO SIGNS OF LOOSING OF THE CONNECTION. THE MALE LUER COLLAR DOES HAVE THE ABILITY TO SPIN AND CAN BE MOVED AWAY FROM THE SOLID INNER PLASTIC TUBING IF THE USER ALIGNS THE GROOVE OF THE DESIGN CORRECTLY. THERE IS NOT A DEFECT IN THE COMPONENT. A DEVICE HISTORY RECORD REVIEW FOR MODEL MZX5306 LOT NUMBER 22029806 WAS PERFORMED. A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE FAILURE REPORTED COULD NOT BE REPRODUCED AND VERIFIED. FURTHER INVESTIGATION INTO THE LUER INDICATES THAT THERE ARE TWO APPROVED STYLES OF LUERS FOR THIS ASSEMBLY. ONE OF THE APPROVED CONSTRUCTIONS ALLOWS FOR THE SECUREMENT COLLAR TO SLIDE DOWN ONTO THE CONNECTED TUBING, THE OTHER APPROVED CONSTRUCTION RESTRICTS THE MOVEMENT OF THE SECUREMENT COLLAR THROUGHOUT THE TUBING ASSEMBLY, AND THEREFORE IS NOT CONSIDERED A DEFECT OR DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING A BD MAXZERO¿ EXTENSION SET THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT " THE IV CATHETER SIDE WAS DOWN ON THE EXTENSION TUBING WAS UNABLE TO USE IT TO CONNECT TO THE IV CATHETER HUB."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING A BD MAXZERO¿ EXTENSION SET THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT " THE IV CATHETER SIDE WAS DOWN ON THE EXTENSION TUBING WAS UNABLE TO USE IT TO CONNECT TO THE IV CATHETER HUB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664991 BD MAXZERO¿ EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22029806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown