BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLR POSITIVE DISPLACEMENT CONN

    MDR report key: 12291763 · Received August 6, 2021

    Report

    Report Number
    9616066-2021-51738
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 9, 2021
    Report Date
    July 29, 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 · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: ONE MP1000C-0006 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; RESIDUAL FLUID WAS PRESENT WITHIN THE COMPONENT. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE CUSTOMER'S EXPERIENCE IN THIS INSTANCE. PRESSURE TESTING OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY LEAKAGE FROM THE COMPONENT; FURTHERMORE A VISUAL INSPECTION OF RETURNED SAMPLE DID NOT IDENTIFY ANY OBVIOUS CRACKS WHICH MAY HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. HOWEVER ANALYSIS OF THE SAMPLE DID IDENTIFY SOME CLOUDINESS AT THE JOINT OF THE MAXPLUS HOUSING AND THE MALE LUER. A VISUAL INSPECTION REVEALED THE PRESENCE OF SMALL WHITE SOLVENT LIKE STRUCTURES WHICH COULD BE SEEN AT THE JOINT BETWEEN THE MALE LUER COMPONENT AND THE BLUE COMPONENT OF THE PRODUCT. HOWEVER NO CRACKS WERE OBSERVED ON THE FEMALE LUER. THE MP1000C-0006 SAMPLE WAS CONNECTED TO A BD PLASTIPAK 60ML SYRINGE FROM STOCK, AND THE MALE LUER WAS OCCLUDED TO IDENTIFY ANY LEAKAGE FROM THE PRODUCT. WHEN PLACED UNDERWATER, NO BUBBLING OCCURRED, INDICATING THAT THESE WHITE STRUCTURES WERE NOT A SOURCE OF LEAKAGE. INVESTIGATION CONCLUSION: ALTHOUGH THIS IS NOT CONSIDERED TO BE A PRODUCT DEFECT, THE MANUFACTURING SITE WILL CONTINUE TO MONITOR REPORTS OF THIS NATURE DURING FUTURE PRODUCTION OF THIS PRODUCT. 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. ROOT CAUSE DESCRIPTION: IN THIS INSTANCE, IT WAS NOT POSSIBLE TO CONFIRM THE CUSTOMER'S EXPERIENCE. PREVIOUS INVESTIGATIONS HAVE CONFIRMED THAT THE OBSERVED CLOUDINESS CAN OCCUR AS A RESULT OF THE ULTRASONIC WELDING PROCESS OF THE MAXPLUS COMPONENT, HOWEVER PLEASE NOTE THIS IS DEEMED COSMETIC DEFECT IN NATURE ONLY AND DOES NOT AFFECT THE FUNCTIONALITY OR INTEGRITY OF THE COMPONENT. THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CRACKS WERE SEEN IN THE MAXPLUS CLR POSITIVE DISPLACEMENT CONN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS REPORTED ANOTHER MAXPLUS CLEAR CONNECTORS SHOWING CRACKS DURING USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184955 MAXPLUS CLR POSITIVE DISPLACEMENT CONN INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1