BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE® NEUTRAL CONNECTOR

    MDR report key: 14597018 · Received June 3, 2022

    Report

    Report Number
    9617594-2022-00156
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    April 1, 2022
    Report Date
    May 9, 2022
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709042377
    PMA / PMN Number
    K970855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RECEIVED; HOWEVER, INVESTIGATION IS STILL PENDING.

    Additional Manufacturer Narrative · 0

    RECEIVED EIGHTY-TWO NEW CLAVE¿ NEUTRAL CONNECTOR WITH LIST #12568 AND LOT #5809423. THIRTY-FIVE OF THE RETURNED SAMPLES WERE RANDOMLY SELECTED AS IF THE WHOLE LOT POPULATION WAS AVAILABLE TO DRAW FROM FOR FUNCTIONAL TESTING. THE SAMPLES WERE DISCONNECTED, AND PRESSURE LEAK TESTED. NO LEAKS OBSERVED IN THE ACTIVATED AND INACTIVATED STATE. THERE WERE NO DISCONNECTIONS NOTED. NO STICK DOWNS OBSERVED DURING MULTIPLE ACTIVATION TEST. RECEIVED 2 PHOTOS SHOWING THE CLAVE CONNECTED ATTACHED TO A CATHETER AND NO DAMAGES OR ANOMALIES NOTED. THE COMPLAINT OF SEPARATION COULD NOT BE CONFIRMED OR REPLICATED. THE LOT HISTORY WAS REVIEWED, AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION: A5 - ETHNICITY, A6 - RACE, B5 - DESCRIBE EVENT OR PROBLEM, AND D10 - PRODUCT.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON UNSPECIFIED DATE ON (B)(6) 2022 INVOLVING A MICROCLAVE® NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT THE HUB OF THE IV IS FALLING OFF/APART, AND AN AIR EMBOLISM WAS IDENTIFIED ON COMPUTED TOMOGRAPHY (CT) ON THE PERIPHERAL SITE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS THE SIXTH OF EIGHT EVENTS.

    Description of Event or Problem · 0

    RECEIVED ADDITIONAL INFORMATIONAL ON 21-JUN-2022 STATING THE FACILITY CONFIRMED PRIMING OF MICROCLAVE AND LUERING ON TIGHTLY. THE CUSTOMER ALSO STATED THAT IN THE COMPUTED TOMOGRAPHY (CT) AREA, WHEN DOING BIOPSY, THEY USE AN EXTENSION SET (ITEM NUMBER 12517-01 FROM ICU MED) AND SYRINGE KIT (ITEM NUMBER SSS-CTP-QFT FROM MEDRAD STELLANT). THEY TYPICALLY CONNECT ANGICATH DIRECTLY TO MICROCLAVE. THE DOCTOR PREFERS THIS METHOD AS IT CREATES CONSISTENT PRESSURE. THEY ALSO USED FLUSH SYRINGE (ITEM NUMBER 306546 FROM BD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587778 MICROCLAVE® NEUTRAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12568 5809423 00887709042377

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EXTENSION SET ITEM #12517-01, ICU MED MFR| FLUSH SYRINGE ITEM #306546, BD MFR| SYRINGE KIT ITEM #SSS-CTP-QFT, MEDRAD STELLANT MFR| UNSPECIFIED IV PRODUCT, MFR UNK