BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M¿ CUROS JET¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS

    MDR report key: 7930409 · Received October 3, 2018

    Report

    Report Number
    2110898-2018-00089
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 18, 2018
    Report Date
    October 3, 2018
    Manufacturer
    3M HEALTH CARE
    Product Code
    LKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CATALOG AND LOT NUMBERS WERE UNKNOWN. WITHOUT A CATALOG OR LOT NUMBER, EXPIRATION DATE, MANUFACTURE DATE AND UDI CANNOT BE DETERMINED. MEDICAL DEVICES: BAXTER® CLEARLINK¿ CONTINU-FLO¿ SOLUTION SYSTEM CATALOG NUMBER 2C8537 AND BAXTER® CLEARLINK¿ EXTENSION SET/IV FILTER LUER ACTIVATED VALVE, CATALOG NUMBER 2H8603 WERE ALSO REPORTEDLY USED. (B)(4). 3M FOUND THIS TO BE AN INTERMITTENT INCOMPATIBILITY ISSUE ASSOCIATED WITH THE IMPACT OF SYSTEM PRESSURE ON SELECT NEEDLELESS CONNECTOR. THE CUSTOMER REPORTED THERE WERE SEVERAL OTHER PATIENTS THAT HAD TPN INFUSING VIA THE SAME SETUP (IV TUBING, CUROS JET¿ DISINFECTING CAPS) AND THOSE PATIENTS DID NOT EXPERIENCE ANY LEAKING. THE CUSTOMER REPORTED THIS PATIENT EXPERIENCED THE EXACT SAME EVENT TWO NIGHTS IN A ROW. 2110898-21018-00088 WAS SUBMITTED FOR THE LEAKING THAT OCCURRED ON (B)(6) 2018 AND 2110898-2018-00089 WAS SUBMITTED FOR THE LEAKING THAT OCCURRED ON (B)(6) 2018. CURRENT PRODUCT LABELING NOTES THE POTENTIAL FOR INTERMITTENT LEAKING WITH BAXTER® CONTINU-FLO¿ SOLUTION SET WITH CLEARLINK¿ LUER ACTIVATED VALVE. PLEASE SEE THE EXACT WORDING BELOW: CAUTION: THERE IS A POTENTIAL FOR INTERMITTENT LEAKING WHEN BAXTER® CONTINU-FLO¿ SOLUTION SET WITH CLEARLINK¿ LUER ACTIVATED VALVE OR BD MAXZERO¿ NEEDLE-FREE CONNECTORS ARE USED UNDER PRESSURE WITH 3M¿ CUROS JET¿ DISINFECTING CAPS (CFJ1-270 AND CFJ5-250.) MONITOR THESE CONNECTORS IF USED UNDER PRESSURE. ALTERNATIVELY, 3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS (CFF1-270 AND CFF10- 250) MAY BE USED. END OF REPORT

    Description of Event or Problem · 1

    A NURSE REPORTED A PATIENT HAD TPN INFUSING INTO A PICC CATHETER VIA AN INFUSION PUMP. THREE CFJ5-250 CUROS JET¿ DISINFECTING CAPS WERE PLACED ON THE THREE NEEDLELESS CONNECTORS (Y-SITES) OF THE IV TUBING. THE PATIENT REPORTEDLY EXPERIENCED LEAKING OF TPN FLUID FROM ONE OF THE NEEDLELESS CONNECTOR/CUROS JET¿ DISINFECTING CAP CONNECTIONS ON TWO OCCASIONS. THE PATIENT REPORTEDLY NOTICED THE LEAKING AND NOTIFIED HIS NURSE IMMEDIATELY. THE NURSE REPORTED A MINIMAL AMOUNT OF TPN HAD LEAKED AND NO PATIENT HARM OCCURRED. THE CUROS JET¿ DISINFECTING CAPS WERE REMOVED FOR THE REMAINDER OF THE TPN INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771281 3M¿ CUROS JET¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS CUROS JET DISINFECTING CAP LKB 3M HEALTH CARE N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR