BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8" (20 CM) EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, Y-CONNECTOR, ROTATING L

    MDR report key: 14227662 · Received April 27, 2022

    Report

    Report Number
    9617594-2022-00103
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 1, 2022
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00887709081338
    PMA / PMN Number
    K131549
    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 HAS BEEN RECEIVED FOR EVALUATION, HOWEVER, EVALUATION IS NOT YET COMPLETE. INITIAL REPORTER - ADDITIONAL TELEPHONE NUMBERS: 1-800-565-8444 AND (B)(6).

    Additional Manufacturer Narrative · 0

    ONE USED LIST #CL3950, 8" (20 CM) EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, Y-CONNECTOR, ROTATING LUER; LOT #5629224 WAS RECEIVED FOR EVALUATION. NO ANOMALIES WERE OBSERVED UPON VISUAL INSPECTION. THE SET WAS TESTED PER PRODUCT SPECIFICATIONS. A CHANNEL LEAK WAS FOUND AT THE CHEMOLOCK BOND INTERFACE. LIGHT UNSCREWING TORQUE SEPARATED THE CHEMOLOCK PORT FROM THE Y-CONNECTOR BOND INTERFACE. VISUAL EXAMINATION OF THE BOND INTERFACE SHOWED THAT THERE WAS SOLVENT AROUND BOND INTERFACE. THE PROBABLE CAUSE OF THE LEAKAGE IS A MANUAL BONDING ERROR DURING ASSEMBLY. LOT HISTORY REVIEW WAS PERFORMED AND NO RELEVANT NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 8" (20 CM) EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, Y-CONNECTOR, ROTATING LUER WHICH REPORTEDLY LEAKED VESICANT IV DRUG DURING PATIENT INFUSION. APPROXIMATELY 2-3 ML OF THE DRUG WHICH WAS CONTAINED ON A 4X4 GAUZE AND BLUE PAD BUT A SMALL AMOUNT OF DRUG DID LEAK ONTO THE PATIENTS FINGERS. THE PATIENT'S HANDS WERE WASHED WITH WARM WATER AND SOAP. THE USER STOPPED PUSHING THE DRUG AND ASSESSED WHERE THE LEAK MAY BE COMING FROM AFTER REMOVING THE SYRINGE FILLED WITH THE DRUG. THE EXTENSION SET MICROCLAVE CLEAR CHEMOLOCK PORT Y CONNECT WAS REMOVED FROM THE IV TUBING AND SAVED IN A BLUE PAD AND CLEAR BAG AND REPLACED AND THE REMAINING TREATMENT WAS COMPLETED. THERE WAS NO UNEXPECTED OR PROLONGED CARE HAPPENED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027834 8" (20 CM) EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, Y-CONNECTOR, ROTATING L CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5629224 00887709081338

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED VESICANT IV DRUG, MFR UNK