BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE

    MDR report key: 16850308 · Received May 1, 2023

    Report

    Report Number
    9616066-2023-00799
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    April 1, 2023
    Report Date
    July 5, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403237218
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE UNUSED SAMPLE WAS RECEIVED AND TESTED BY OUR QUALITY TEAM. THE SET WAS TESTED THOROUGHLY AND THERE WERE NO ISSUES WITH LEAKAGE AFTER INFUSION. THE SET WAS ALSO PULL TESTED WITH GREATER TENSILE FORCE THAN SHOULD EVER BE APPLIED IN A CLINICAL SETTING AND NO SEPARATION WAS REALIZED. WITHOUT FURTHER INFORMATION LIKE PHOTOS OF THE AFFECTED DEVICE OR THE DEVICE ITSELF FOR TESTING THE COMPLAINT OF SEPARATION CANNOT BE VERIFIED AND THE ROOT CAUSE REMAINS UNKNOWN. A DEVICE HISTORY RECORD REVIEW FOR MODEL MPX5300-C LOT NUMBER 22109049 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE BUILD OF THIS SET. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE SEPARATED AT THE BONED JOINT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FAILURE OF A BONDED JOINT ON THEIR EXTENSION SET. THE PRODUCT WHICH FAILED DURING PT CARE WAS NOT KEPT. HOWEVER, THE ASSISTANT NURSE MANAGER AT THE MWH ED STATED THAT OTHER UNITS HE ¿TESTED¿ HAVE ALSO COME APART RELATIVELY EASILY AT THE BONDED JOINT.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE SEPARATED AT THE BONED JOINT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FAILURE OF A BONDED JOINT ON THEIR EXTENSION SET. THE PRODUCT WHICH FAILED DURING PT CARE WAS NOT KEPT. HOWEVER, THE ASSISTANT NURSE MANAGER AT THE MWH ED STATED THAT OTHER UNITS HE ¿TESTED¿ HAVE ALSO COME APART RELATIVELY EASILY AT THE BONDED JOINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152669 BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22109049 10885403237218

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown