BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE® CLEAR NEUTRAL CONNECTOR

    MDR report key: 17756036 · Received September 15, 2023

    Report

    Report Number
    9617594-2023-00718
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    June 28, 2023
    Report Date
    November 10, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K100434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. PLOT REPORTED: LOT 9975759, MANUFACTURED DATE 10/1/2022,   EXPIRATION DATE 9/1/2027. LOT 5802846,  MANUFACTURED DATE 01/1/2022,   EXPIRATION DATE 1/1/2027. LOT  13493326, MANUFACTURED DATE 12/1/2022,   EXPIRATION DATE  12/1/2027. LOT 13456038,  MANUFACTURED DATE 11/1/2022,   EXPIRATION DATE 11/1/2027. LOT 11798747, MANUFACTURED DATE 11/1/2022,   EXPIRATION DATE  11/1/2027.

    Additional Manufacturer Narrative · 0

    TWO (2) USED SAMPLES LIST #MC100 WERE RETURNED FOR EVALUATION. AS RECEIVED IN BOTH SAMPLE A DAMAGE ON THE SEAL WAS OBSERVED. ADDITIONAL IN ONE OF THE MICROCLAVE A COMBINATION TPN AND SMOF LIPID RESIDUALS WAS OBSERVED. NO ADDITIONAL DAMAGE OR ANOMALIES WERE OBSERVED. BOTH MICROCLAVES WERE PRIMED AS PER PROCEDURE AND ONE OF THEM PRESENTED AN INTERNAL LEAKS. ONCE BOTH SAMPLES WERE DISSEMBLED A SLIT PROPAGATION ON THE SEAL THAT EXTENDED TILL THE SIDE WERE OBSERVED. COMPLAINT OF LEAKS CAN BE CONFIRMED DUE TO THE SLIT PROPAGATION OBSERVED ON THE SEAL. THE PROBABLE CAUSE IS TYPICAL DUE TO INCOMPATIBLE MATING DEVICE DURING USE, DFU STATES: THE CLAVE CONNECTOR IS COMPATIBLE WITH LUERS WITH AN INTERNAL DIAMETER (ID) BETWEEN 0.062" AND 0.110". THE DEVICE HISTORY RECORDS FOR POSSIBLE LOTS#13456038, 9975759, 13493326, 5802846, 13456038, AND 11798747 WERE REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED THE REPORTED COMPLAINT. D9: PRODUCT WAS RECEIVED ON 10/25/2023.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF LEAKS ON ITEM MC100 COULD NOT BE CONFIRMED BY INVESTIGATION. SINCE NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A PROBABLE CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR THE POSSIBLE LOTS#13456038, 9975759, 13493326, 5802846, 13456038, AND 11798747 WERE REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED THE REPORTED COMPLAINT. UPDATED INFORMATION D9- SAMPLE WAS NO LONGER AVAILABLE

    Description of Event or Problem · 0

    THE EVENT INVOLVED MICROCLAVE® CLEAR NEUTRAL CONNECTOR THE USER WENT TO PERFORM A LINE CHANGE ON THE PATIENT AND NOTED THAT THE BUNG ATTACHED TO THE CENTRAL LINE HAD FLUID LEAKED INTO THE MAIN ACCESS PORT. THE PRODUCT DID NOT LOOK DAMAGED TO THE NAKED EYE BUT THE USER ASSUMED THERE MIGHT BE SOME MALFUNCTION/DEFECT, SO THE CAP WAS REMOVED AND SAVED AT THE PATIENT'S BEDSIDE. CAP CHANGED AS PER POLICY UNDER STERILE TECHNIQUE. UPON INSPECTION AFTER REMOVAL, THE CAP FILLED WITH COMBINATION TPN AND SMOF LIPID, AND NOTED TO HAVE A SLICE IN THE PLASTIC OF THE PLUNGER AT THE LEUR LOCK END. UNFORTUNATELY, AS THIS WAS AN EXISTING LINE AND NOT A NEW PRIME, THERE WAS NO PACKAGING SAVED. NICU NORTH HAD 5 DIFFERENT LOT NUMBERS OF THE END CAP SO UNABLE TO DETERMINE IF ANY CORRELATION. IT IS UNKNOWN HOW LONG THE INFUSION BUT LIKELY NOT A LONG TIME AS NURSING WOULD HAVE PICKED UP ON IT. THERE WAS A SLICE NOTED IN THE PLASTIC OF THE PLUNGER AT THE LUER LOCK END. THERE WAS NO BLOOD LOSS OR BLEED BACK. THE CAP WAS CHANGED AS PER POLICY, UNDER THE STERILE TECHNIQUE. HE ANSWERED OTHER THAN CHANGING THE CAP, THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO HARM WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290298 MICROCLAVE® CLEAR NEUTRAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CAP, MFR UNK.| CENTRAL LINE, MFR UNK.| MAIN ACCESS PORT, MFR UNK.| SMOF LIPID, MFR UNK.| TOTAL PARENTERAL NUTRITION, MFR UNK.