BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS

    MDR report key: 6894041 · Received September 26, 2017

    Report

    Report Number
    2110898-2017-00128
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    August 17, 2017
    Report Date
    September 26, 2017
    Manufacturer
    3M HEALTH CARE
    Product Code
    LKB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THE CATALOG NUMBER FOR THIS REPORT WAS CFF1-270 (OR CFF 10-250). CFF1-270 ARE INDIVIDUAL CAPS AND CFF10-250 ARE STRIPS(10 CAPS /STRIP). OPERATOR OF DEVICE WAS UNKNOWN. CUSTOMER REPORTED THE PATIENT'S HICKMAN CATHETER WAS USED FOR DAILY HOME INFUSIONS OF TPN. TYPE OF REPORTABLE EVENT. THIS REPORT DID NOT INVOLVE A DEATH, SERIOUS INJURY OR A MALFUNCTION. MALFUNCTION WAS SELECTED FOR THIS REPORT BECAUSE A SELECTION WAS REQUIRED FOR THIS SECTION OF THE REPORT. THE CUSTOMER REPORT NOTED THAT CUROS CAPS ARE NOT INTENDED TO ATTACH TO A FEMALE LUER HUB AND ARE DESIGNED TO BE USED ON NEEDLELESS CONNECTORS. THE PRODUCT PACKAGING INCLUDES THE FOLLOWING WARNING AND CAUTIONARY STATEMENTS: WARNING: TO AVOID POTENTIAL INJURY - USE ONLY ON NEEDLELESS CONNECTORS. THE PACKAGE INSERT STATES THE FOLLOWING INFORMATION RELATED TO INTENDED USE AND INSTRUCTIONS FOR USE: INTENDED USE: THE CUROS¿ DISINFECTING CAP IS INTENDED FOR USE ON NEEDLELESS CONNECTORS ONLY AS A DISINFECTING CLEANER PRIOR TO I.V. ACCESS AND TO ACT AS A COVER BETWEEN LINE ACCESSES...... INSTRUCTIONS FOR USE: WARNING: TO AVOID POTENTIAL FOR INJURY - USE ONLY ON NEEDLELESS CONNECTORS...... IN ADDITION, 3M PROVIDES TRAINING MATERIALS (INCLUDING GRAPHICS) INSTRUCTING CUSTOMERS TO APPLY THE CUROS CAP ONLY TO NEEDLELESS CONNECTORS AND NOT TO APPLY THE CUROS CAP DIRECTLY TO A CATHETER HUB. IN SUMMARY, THE PRODUCT PACKAGING AND INSTRUCTIONS FOR USE CLEARLY STATE VIA A WARNING THAT THE PRODUCT SHOULD ONLY BE USED ON NEEDLELESS CONNECTORS.

    Description of Event or Problem · 1

    AN INTERVENTIONAL RADIOLOGIST REPORTED AN OUTPATIENT PRESENTED WITH A NONFUNCTIONING HICKMAN CATHETER LINE. A SPONGE FROM A CUROS CAP WAS FOUND IN THE FEMALE LUER CATHETER HUB AND WAS REMOVED. NO INJURY WAS REPORTED, THE PATIENT WAS BEING MONITORED FOR SIGNS AND SYMPTOMS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674363 3M CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS LKB 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other