BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLR POSITIVE DISPLACEMENT CONN

    MDR report key: 12305022 · Received August 10, 2021

    Report

    Report Number
    9616066-2021-51753
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 13, 2021
    Report Date
    August 18, 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: 2021-07-22. H6: INVESTIGATION SUMMARY: ONE MP1000C-0006 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION. THE CUSTOMER FEEDBACK INDICATES THAT THE SAMPLE WAS FROM LOT 20016605. NO CONNECTING PRODUCTS WERE RECEIVED. A VISUAL INSPECTION CONFIRMED THE CUSTOMER'S EXPERIENCE AS A CRACK WAS IDENTIFIED ON THE FEMALE LUER OF THE MAXPLUS COMPONENT; 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 LOT 20016605 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE, 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. FROM THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO SPECULATE WHICH OF THESE FACTORS WERE KEY CONTRIBUTORS TO THE REPORTED ISSUE. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXPLUS CLR POSITIVE DISPLACEMENT CONN STOPPER CRACKED/SPLIT FROM THE CONNECTION END AND LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR TPN SERVICES NURSES HAVE MADE CONTACT AS THERE HAVE BEEN A NUMBER OF MAXPLUS BUNGS THAT HAVE SPLIT/CRACKED FROM THE CONNECTION END. THE PATIENTS THEMSELVES REPORT THAT TPN WAS LEAKING FROM THE BUNG."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXPLUS CLR POSITIVE DISPLACEMENT CONN STOPPER CRACKED/SPLIT FROM THE CONNECTION END AND LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR TPN SERVICES NURSES HAVE MADE CONTACT AS THERE HAVE BEEN A NUMBER OF MAXPLUS BUNGS THAT HAVE SPLIT/CRACKED FROM THE CONNECTION END. THE PATIENTS THEMSELVES REPORT THAT TPN WAS LEAKING FROM THE BUNG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196252 MAXPLUS CLR POSITIVE DISPLACEMENT CONN INTRAVASCULAR ADMINISTRATION SET FPA 20016605

    Patients

    Seq Age Sex Outcome Treatment
    1