BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLR POSITIVE DISPLACEMENT CONN

    MDR report key: 12502283 · Received September 20, 2021

    Report

    Report Number
    9616066-2021-52081
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    July 13, 2021
    Report Date
    September 28, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-09-01. H6: INVESTIGATION SUMMARY. TWO MP1000C-0006 PRODUCTS WERE RECEIVED WITHOUT PACKAGING FOR INVESTIGATION. THE CUSTOMER FEEDBACK INDICATE THE AFFECTED PRODUCT WAS FROM LOT 20056572, 20065649 OR 20065650. NO CONNECTING PRODUCTS WERE RECEIVED TO ASSIST THE INVESTIGATION. FURTHER INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT THE DAMAGE WAS OBSERVED EARLY ON INTO USE, AND THE MAXPLUS COMPONENTS WERE CONNECTED TO BD EXTENSION SETS; ADDITIONALLY THE CUSTOMER CONFIRMED THAT THE MAXPLUS ARE TYPICALLY DISINFECTED WITH 3M SOLUPREP ANTISEPTIC WIPES 92%W/V CHLORHEXIDINE GLUCONATE AND 70% V/V ISOPROPYL ALCOHOL. A VISUAL INSPECTION OF THE RECEIVED SAMPLES CONFIRMED THE CUSTOMER'S EXPERIENCE AS A CRACK WAS IDENTIFIED ON THE FEMALE LUER ADAPTOR OF THE MAXPLUS COMPONENTS; IN EACH INSTANCE LEAKAGE WAS OBSERVED FROM THE CRACK. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOTS 20056572, 20065649 AND 20065650 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE TYPE OF CRACK OBSERVED CAN BE CAUSED OR CONTRIBUTED TO BY A COMBINATION OF DIFFERENT FACTORS, INCLUDING OVER-TORQUE OF THE COMPONENT DURING CONNECTION WITH THE MALE LUER, USE OF A MALE LUER THAT IS NOT COMPLIANT TO ISO STANDARDS, OR PROLONGED USE OF SUBSTANCES THAT ARE AGGRESSIVE TO PLASTICS. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT COMPLAINTS OF THIS NATURE ARE RARE AND THERE IS CURRENTLY NO TREND FOR ISSUES OF THIS NATURE AGAINST THE MAXPLUS PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 MAXPLUS CLR POSITIVE DISPLACEMENT CONN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS THE THIRD REPORTED OCCURRENCE OF A CRACKED CONNECTOR. THESE WERE NOT KEPT FOR MY PERUSAL."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 MAXPLUS CLR POSITIVE DISPLACEMENT CONN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS THE THIRD REPORTED OCCURRENCE OF A CRACKED CONNECTOR. THESE WERE NOT KEPT FOR MY PERUSAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399382 MAXPLUS CLR POSITIVE DISPLACEMENT CONN INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1