BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER

    MDR report key: 8671759 · Received June 5, 2019

    Report

    Report Number
    9617594-2019-00162
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 22, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709036512
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - ONE (1) USED K181-001 9" (23 CM) SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER, NON-DEHP TUBING AND ONE USED CLEAR MICROCLAVE ATTACHED AT THE DISTAL END WAS RECEIVED FOR EVALUATION. THE EXTENSION SET WAS PRESSURE LEAK TESTED WITH THE CLEAR MICROCLAVE ATTACHED AT THE DISTAL END. NO LEAKAGE WAS OBSERVED. THE CLEAR MICROCLAVE WAS REMOVED FROM THE EXTENSION SET AND NO LEAKAGE WAS OBSERVED. THE Y-CLAVE OF THE EXTENSION SET WAS RETURNED WITH THE SEAL STUCK DOWN AND SUBSEQUENT DISASSEMBLY REVEALED AN AXIAL SEAL RUPTURE. THERE WAS NO PHYSICAL DAMAGE TO THE SPIKE OR BODY. NO MATING DEVICES WERE RETURNED THAT WOULD HAVE BEEN CONNECTED TO THE Y-CLAVE. THE MAINTENANCE REPORTS AND LOT HISTORY FOR THE INDICATED LOT WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES OR MALFUNCTIONS NOTED. THE COMPLAINT OF LEAKAGE WAS CONFIRMED AT THE Y-CLAVE THAT WAS RETURNED STUCK DOWN. THE PROBABLE CAUSE OF THE AXIAL SEAL RUPTURE IS NOT KNOWN.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. TESTING IS NOT COMPLETE. CONCOMITANT MEDICAL PRODUCTS: MICROBORE EXTENSION SET, REF (B)(4) LOT 0061635056, MFR B. BRAUN MEDICAL, INC; GANCICLOVIR, MFR UNK.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A 9¿ SMALLBORE EXT SET, CLAVE, CLAMPS, ROTATING LUER, THAT WAS ATTACHED TO A B. BRAUN MEDICAL, INC, MICROBORE EXTENSION SET, THAT THE CUSTOMER REPORTED INVOLVED A BABY IN THE NEONATAL INTENSIVE CARE UNIT THAT HAD AN IMAGE GUIDED THERAPY PERIPHERALLY INSERTED CENTRAL CATHETER (IGT PICC) WITH A DACRON CUFF PLACED FOR LONG TERM ANTI-VIRAL TREATMENT AT ANOTHER FACILITY. AT AN UNSPECIFIED TIME, AFTER THE INFUSION OF GANCICLOVIR WAS COMPLETED, THE PORT WAS FLUSHED WITH 0.9% SODIUM CHLORIDE. APPROXIMATELY ONE HOUR LATER, BLOOD WAS NOTED TO BE ON THE LINEN AND THE SILICONE CENTER OF THE CLAVE WAS NOTED TO BE DEPRESSED. THE CUSTOMER REPORTED THAT IT WAS UNCLEAR WHEN THE CLAVE BECAME DEPRESSED, EITHER WITH THE MEDICATION INFUSION OR SALINE FLUSH STATING THAT THERE WAS NOT AN OBVIOUS DEFECT OF THE CLAVE SEEN UNTIL THE DEPRESSED SILICONE CENTER BECAME EVIDENT. THE PICC WAS REPORTED TO BE CUFFED AND WAS UNABLE TO BE REMOVED FOR SAFETY/INFECTION PREVENTION MEASURES. THERE WAS AN ESTIMATED BLOOD LOSS OF 3ML, FOLLOWED BY A CLOT FORMING IN A DIFFERENT CLAVE ATTACHED TO THE END OF THE PICC. THE CLAVE AND T-PIECE WERE REPLACED AND THE LINE WAS FLUSHED. THE PICC LINE WAS LEFT INSITU. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463256 9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3979592 00887709036512

    Patients

    Seq Age Sex Outcome Treatment
    1