BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 3-LUMEN 7 FR X 16 CM

    MDR report key: 10065563 · Received May 18, 2020

    Report

    Report Number
    3006425876-2020-00458
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    May 4, 2020
    Report Date
    May 5, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 3-LUMEN CVC AND STOPCOCK FOR EVALUATION. INITIAL VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS OR ANOMALIES. AFTER THE CATHETER FAILED FUNCTIONAL TESTING , THE MEDIAL LUMEN WAS MICROSCOPICALLY EXAMINED. A SMALL SLIT WAS FOUND IN THE MEDIAL LUMEN ADJACENT TO THE JUNCTURE HUB. THE EDGES OF THE SLIT WERE SMOOTH AND UNIFORM, INDICATING THAT THE LUMEN CAME IN CONTACT WITH A SHARP OBJECT (SCISSORS, NEEDLE, SCALPEL, ETC.). THE SMALL SLIT IN THE MEDIAL LUMEN WAS LOCATED 2 MM FROM THE DISTAL END OF THE JUNCTURE HUB. THE INNER DIAMETER OF THE MEDIAL LUMEN MEASURED TO BE 1.47 MM WHICH IS WITHIN SPECIFICATIONS OF 1.42-1.50 MM PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE MEDIAL EXTENSION LINE MEASURED TO BE 2.15 MM WHICH IS WITHIN SPECIFICATIONS OF 2.13-2.21 MM PER PRODUCT DRAWING. THIS INDICATES THAT THE WALL THICKNESS MEASURED WITHIN SPECIFICATIONS. ALL THREE EXTENSION LINES WERE INITIALLY FLUSHED TO ENSURE NO BLOCKAGES WERE PRESENT. WHEN FLUSHING THE BLUE (MEDIAL) LUMEN, A SMALL LEAK WAS DETECTED ADJACENT TO THE JUNCTURE HUB. THE PROXIMAL AND DISTAL LUMENS FUNCTIONED AS EXPECTED. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT SECURE, STAPLE AND/OR SUTURE DIRECTLY TO OUTSIDE DIAMETER OF CATHETER BODY OR EXTENSION LINES TO REDUCE RISK OF CUTTING OR DAMAGING THE CATHETER OR IMPEDING CATHETER FLOW. SECURE ONLY AT INDICATED STABILIZATION LOCATIONS." THE CUSTOMER REPORT OF AN EXTENSION LINE LEAK WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE MEDIAL LUMEN CONTAINED ONE SMALL SLIT ADJACENT TO THE JUNCTURE HUB. THE APPEARANCE OF THE SLIT WAS CONSISTENT WITH THE LUMEN COMING IN CONTACT WITH A SHARP OBJECT (NEEDLE, SCISSORS, SCALPEL, ETC.). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON SALES HISTORY WITH NO RELEVANT FINDINGS. BASED ON THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 15-YEAR-OLD GIRL GETS INFUSION OF NA (NORD ADRENALINE) TO SUPPORT LOW BP. THE GIRL'S CONDITION WAS IMPROVING BUT DUE TO LOW BP THEY INCREASED NA (NORD ADRENALINE). DUE TO LACK OF NA (NORD ADRENALINE) EFFECT, BP DECREASES FURTHER. NO EFFECT BECAUSE OF LEAKAGE IN CVC. THE DECREASING PRESSURE IN THE BRAIN RESULTED IN BRAIN EDEMA. THE INCIDENT OCCURRED 10 DAYS AFTER INSERTION OF THE DEVICE. CLINICAL CONSEQUENCES: OPERATED SUBSEQUENTLY TO AVOID INCARCERATION. HER CONDITION IS VERY SERVER. THE DEVICE WAS INSERTED JUGULARS INTERNAL DXT. THE DEVICE WAS REPLACED , AND THE PATIENT GOT AN OPERATION AND MEDICATION. TIOMEBUMAL, RELAXANTIA, HYPOTONIC SALINE, BILATERAL CRANIECTOMY, SHOCK REVERSE STEROID TREATMENT. THE SEQUEL IS BRAIN DAMAGED.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD GIRL GETS INFUSION OF NA (NORD ADRENALINE) TO SUPPORT LOW BP. THE GIRL'S CONDITION WAS IMPROVING BUT DUE TO LOW BP THEY INCREASED NA (NORD ADRENALINE). DUE TO LACK OF NA (NORD ADRENALINE) EFFECT, BP DECREASES FURTHER. NO EFFECT BECAUSE OF LEAKAGE IN CVC. THE DECREASING PRESSURE IN THE BRAIN RESULTED IN BRAIN EDEMA. THE INCIDENT OCCURRED 10 DAYS AFTER INSERTION OF THE DEVICE. CLINICAL CONSEQUENCES: OPERATED SUBSEQUENTLY TO AVOID INCARCERATION. HER CONDITION IS VERY SEVERE. THE DEVICE WAS INSERTED JUGULARS INTERNAL DXT. THE DEVICE WAS REPLACED , AND THE PATIENT GOT AN OPERATION AND MEDICATION. TIOMEBUMAL, RELAXANTIA, HYPOTONIC SALINE, BILATERAL CRANIECTOMY, SHOCK REVERSE STEROID TREATMENT. THE SEQUEL IS BRAIN DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529665 CVC SET: 3-LUMEN 7 FR X 16 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other| R