BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS

    MDR report key: 9122572 · Received September 26, 2019

    Report

    Report Number
    2110898-2019-00114
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    August 24, 2019
    Report Date
    September 26, 2019
    Manufacturer
    3M HEALTH CARE
    Product Code
    QBP
    PMA / PMN Number
    K111992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO LOT NUMBER PROVIDED FOR THE PRODUCT. WITHOUT A LOT NUMBER, THE EXPIRATION DATE OR MANUFACTURE DATE COULD NOT BE DETERMINED. 3M RECEIVED MEDWATCH REPORT MW5089371 FROM THE FDA. INITIAL REPORTER'S CONTACT INFORMATION WAS NOT PROVIDED, THOUGH REQUESTED BY 3M. NO SAMPLE OR LOT NUMBER WERE PROVIDED, THEREFORE ADDITIONAL INVESTIGATION COULD NOT BE CONDUCTED. THE COMPLAINT IS ASSOCIATED WITH THE MISUSE OF THE CUROS¿ PRODUCT. CUROS¿ DISINFECTING CAPS FOR NEEDLELESS CONNECTORS ARE DESIGNED ONLY FOR NEEDLELESS CONNECTORS. INTENDED USE STATEMENT IN IFU STATES AS FOLLOWS: "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." IN ADDITION, THE IFU ALSO STATES THE FOLLOWING WARNING: "WARNING: TO AVOID POTENTIAL INJURY - USE ONLY ON NEEDLELESS CONNECTORS." THE OBSERVATION OF THE RING SEPARATING FROM THE CAP OCCURRED DURING THE MISUSE OF THE PRODUCT.

    Description of Event or Problem · 1

    THE FDA NOTIFIED 3M OF A PRODUCT PROBLEM VIA A MEDWATCH REPORT. A NURSE REPORTED THE FOLLOWING INFORMATION TO THE FDA: THE 3M CUROS / 70% IPA CAPS THAT ARE USED TO CAP PICC LINE HUB WAS DEFECTIVE. WHEN THE RN WENT TO DRAW BLOOD FROM THE PICC LINE FOR LAB DRAW, THE DOUBLE LUMEN RED PORT THAT WAS COVERED WITH THE CUROS CAP WAS EASILY REMOVABLE WITHOUT APPARENT DEFECT AND IT ALLOWED SALINE TO BE EASILY FLUSHED INTO THE PICC LINE, BUT WHEN DRAWING BACK TO WASTE AND DRAW BLOOD, THE BLOOD WAS COMING OUT FROTHY WITH AIR BUBBLES. THE NURSE WAS TROUBLESHOOTING THE SYSTEM AND REPEATEDLY ON EACH DRAWBACK, APPROX THREE ATTEMPTS THE SYRINGE WAS FILLING WITH BLOODY AIR BUBBLES. THE NURSE EXPELLED THE AIR BUBBLES INTO THE TRASH CAN TO PREVENT THE AIR BUBBLES FORM INADVERTENTLY GOING INTO THE PICC LINE. THE CUROS 3M GREEN CAP WAS FOUND TO HAVE BROKEN AND A THIN RIM OF GREEN WAS SEEN ON THE PICC LINE RED PORT ACCESS THAT WAS BEING USED FOR THE DRAW. ONCE THE THIN GREEN BROKEN PIECE OF THE CUROS 3M CAP WAS REMOVED, THE PICC LINE WAS ABLE TO DRAW BLOOD WITHOUT AIR BUBBLES. IT WAS VERY UNEXPECTED AND POTENTIALLY DANGEROUS FOR THE PICC LINE TO NOT BE OPERATING PROPERLY BECAUSE OF THE CUROS CAP BEING DEFECTIVE AND BREAKING. LEAVING A THIN RIM THAT PREVENTED AN AIR TIGHT SEAL THAT CAUSED AIR BUBBLING WHEN DRAWING BACK. THIS PROBLEM MAY NOT HAVE BEEN EASILY IDENTIFIED BY ANOTHER NURSE AND IT COULD HAVE RESULTED IN SERIOUS AND LIFE THREATENING ACCIDENT IF AIR HAD BEEN INJECTED INTO A PICC LINE. THIS DEFECT HAS NEVER BEEN WITNESSED BY THIS NURSE OR ANY OTHER NURSES THAT WERE WORKING THAT DAY. FDA SAFETY REPORT ID#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920453 3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS QBP 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1