BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE MANIFOLD, CHECK VA

    MDR report key: 10448734 · Received August 25, 2020

    Report

    Report Number
    9617594-2020-00338
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 4, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    D10: DATE RETURNED TO MANUFACTURER: SEPTEMBER 8, 2020. H10: ONE USED LIST# 011-AM6118, PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, NANOCLAVE® (RED RINGS), ROTATING LUER, LOT# 4780715 WAS RECEIVED FOR EVALUATION. THE COMPLAINT OF LEAKAGE CAN BE CONFIRMED ON THE RETURNED USED 011-AM6118 PROXIMALE SMALLBORE EXT SET W/6-PORT NANOCLAVE. THE PHOTO RETURNED SHOWED THE MANIFOLD WITH THE ONE NANOCLAVE BODY BEING DETACHED. AS RECEIVED ONE OF THE NANO RED RING BODY WAS DETACHED FROM THE MANIFOLD. THE SILICONE SEAL OF THAT NANOCLAVE WAS NOT RETURNED. THERE WAS PLASTIC DEFORMATION ON THE BASE OF THE NANOCLAVE. THERE WAS ALSO SIMILAR DEFORMATION ON THE BODY OF THE NANOCLAVE THAT WAS DETACHED. THE INTERNAL SPIKE WAS BENT IN THE OPPOSITE DIRECTION OF THE PLASTIC DEFORMATION. THE DAMAGES OBSERVED ARE TYPICAL OF AN UNINTENTIONAL BENDING FORCE DURING USE. THE PROBABLE CAUSE OF THE DAMAGES OBSERVED AND SUBSEQUENT LEAKAGE IS DUE TO UNINTENTIONAL BENDING FORCE DURING USE. A DHR LOT# 4780715 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER IDENTIFIED ONE POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 4780715 (EXPIRATION DATE 04/01/2025 , MFR DATE 04/01/2020).

    Description of Event or Problem · 1

    THE EVENT INVOLVED A PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, NANOCLAVE® (RED RINGS), ROTATING LUER WHERE A LEAK WAS NOTED AT THE CHANNEL WHERE THE PSE TUBING WAS CONNECTED DURING AN INFUSION OF NORADRENALINE RESULTING IN A TEMPORARY ARTERIAL PRESSURE DROP FOR THE PATIENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE DEVICE WAS REPLACED. THERE WAS NO PHYSICAL DEFECT NOTED ON THE TUBING. THERE WAS NO REPORT OF ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913101 PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE MANIFOLD, CHECK VA STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 NORADRENALINE, MFR UNK| UNSPEC PSE TUBING, MFR UNK