BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC CATHETERIZATION 4-STATION HIGH PRESSURE STOPCOCK MANIFOLD (OFF HANDLES)

    MDR report key: 12521833 · Received September 23, 2021

    Report

    Report Number
    9617594-2021-00264
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    August 26, 2021
    Report Date
    August 26, 2021
    Product Code
    DQO
    UDI-DI
    00887709043312
    PMA / PMN Number
    K932141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF LEAKAGE WAS CONFIRMED. NO PRODUCT SAMPLES, VIDEOS WERE RETURNED FOR INVESTIGATION. HOWEVER AN IMAGE WAS PROVIDED BY THE CUSTOMER SHOWING A CRACK ON THE FEMALE LUER. CRAZING WAS OBSERVED AROUND THE CRACK IN THE IMAGE PROVIDED BY THE CUSTOMER. THE PROBABLE CAUSE OF THE CRACK ON THE FEMALE LUER HAD OCCURRED DUE TO ENVIRONMENTAL STRESS CRACKING DURING USE. THE DEVICE HISTORY REVIEW (DHR) FOR LOT 5190028 WAS REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE TO EVALUATION HOWEVER IT HAS NOT YET BEEN RECEIVED. 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 5190028 (EXPIRY DATE 02/01/2024, MFR DATE 02/01/2021).

    Description of Event or Problem · 1

    THE EVENT INVOLVED A CARDIAC CATHETERIZATION 4-STATION HIGH PRESSURE STOPCOCK MANIFOLD (OFF HANDLES). THE CUSTOMER REPORTED THAT THE DEVICE CRACKED AND FOUND IT TO BE LEAKING. THE CRACK WAS LOCATED ON THE HUB WHERE THE INTRAVENOUS (IV) TUBING IS CONNECTED TO THE MANIFOLD. THE FOLLOWING MEDICATIONS WERE REPORTED TO BE INFUSING NOREPINEPHRINE, VASOPRESSIN, EPINEPHRINE, AND PROPOFOL, HOWEVER THEY ARE UNSURE WHICH PORT WAS USED FOR EACH DRUG. THE PATIENT'S BLOOD PRESSURE DROPPED DANGEROUSLY LOW AND NECESSITATED SOME CHEST COMPRESSIONS BY THE CARDIOTHORACIC SURGEON IN THE ROOM. THE PATIENT'S BLOOD PRESSURE WAS STABILIZED WHEN THE IV WAS REROUTED. THE IV TUBING WAS THE ONLY THING CONNECTED TO THAT PORT. THERE WAS PATIENT INVOLVEMENT AND A REPORT OF ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415845 CARDIAC CATHETERIZATION 4-STATION HIGH PRESSURE STOPCOCK MANIFOLD (OFF HANDLES) CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO PLOTS 00887709043312

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R EPINEPHRINE, MFR UNK| NOREPINEPHRINE, MFR UNK| PROPOFOL, MFR UNK| UNSPECIFIED TUBING SET, MFR UNK| VASOPRESSIN, MFR UNK| EPINEPHRINE, MFR UNK| NOREPINEPHRINE, MFR UNK| PROPOFOL, MFR UNK| UNSPECIFIED TUBING SET, MFR UNK| VASOPRESSIN, MFR UNK