BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE® NEUTRAL CONNECTOR

    MDR report key: 15986317 · Received December 15, 2022

    Report

    Report Number
    9617594-2022-00323
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    November 16, 2022
    Report Date
    November 30, 2022
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619045593
    PMA / PMN Number
    K100434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RECEIVED BY THE MANUFACTURER ON 15-DEC-2022. THE SINGLE USED B3300 CLAVE NEUTRAL CONNECTOR WAS CONFIRMED TO HAVE BEEN STUCK DOWN AND LEAK AS A RESULT OF BEING STUCK DOWN. SUBSEQUENT DISASSEMBLY REVEALED THAT THE SEAL HAD BEEN CORED AND THE SPIKE BENT; BOTH ARE TYPICAL OF ACCESS WITH AN INCOMPATIBLE MATING DEVICE. THE PROBABLE CAUSE OF B3300 CLAVE NEUTRAL CONNECTOR DAMAGE AND SEAL STICK DOWN AND SUBSEQUENT LEAKAGE IS TYPICAL OF ACCESS WITH AN INCOMPATIBLE MATING DEVICE DURING USE. THE DIRECTIONS FOR USE STATE: CONNECTORS ARE COMPATIBLE WITH ISO MALE LUERS HAVING AN INTERNAL DIAMETER BETWEEN 0.062¿ AND 0.110¿. THE DHR FOR LOT 5800248 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE DEVICE IS EXPECTED; HOWEVER, THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    THE EVEN INVOLVED A MICROCLAVE® NEUTRAL CONNECTOR. THE CUSTOMER REPORTED THAT THEY HAD AN INCIDENT WHERE THE RUBBER STOPPER GOT STUCK INSIDE THE CLAVE AND DID NOT RETRACT OUT, ALLOWING AIR INTO THE LINE. WHEN FOUND, THERE WAS VISIBLE AIR IN THE LINE OF THE PATIENT'S CATHETER. THE ISSUE WAS NOTED UPON REMOVING THE SYRINGE FROM THE CLAVE. THERE WAS APPROXIMATELY 0.3 ML VISIBLE AIR IN THE LINE OUTSIDE OF THE HUBER NEEDLE. IT WAS UNKNOWN IF THERE WAS AIR INFUSED INTO THE PATIENT, BUT THE PATIENT UNDERWENT A CT SCAN TO RULE OUT AIR EMBOLUS. THERE WAS PATIENT INVOLVEMENT BUT NO DELAY IN THERAPY AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734454 MICROCLAVE® NEUTRAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. B3300 5800248 00840619045593

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BD 10 CC 0.9% SODIUM CHLORIDE SYRINGE| BRACCO SULFUR HEXAFLUORIDE INJECTABLE SUSPENSION