BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP402-01 HCR - MICROBORE YELLOW MARKED WITH NON-VENTED SPIKE

    MDR report key: 6150523 · Received December 7, 2016

    Report

    Report Number
    3010293992-2016-00277
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 3, 2016
    Report Date
    March 6, 2017
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FPA
    UDI-DI
    17290109150397
    PMA / PMN Number
    K141834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER, E2014005.

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "UPPER CLAVE ON FILTERED TUBING LEAKED. PATIENT INVOLVEMENT: YES; DEATH/SERIOUS INJURY: NO; HUMAN HARM: NO; DELAY IN THERAPY: NO; MEDICAL INTERVENTION NEEDED: NO".

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(4): "UPPER CLAVE ON FILTERED TUBING LEAKED AND/OR SPIROS ON SECONDARY SET MORE LIKELY THE BLUE CLAVE. COMPLAINT OCCURRED IN JCC CHEMO SUITE. TYPE OF SET USED: FILTERED TUBING. MISSED DOSE: NO. OVER DELIVERY: NO. UNDER DELIVERY: YES, 60MG OF 260. BLOOD LOSS: NO. WAS THERE BLOOD BACKFLOW FROM IV CATHETER: NO. WAS THERE ANY AIR INFUSED: NO. WHAT WAS THE LENGTH OF TIME THE SET WAS IN USE BEFORE THE INCIDENT OCCURRED? 1HR. CONSEQUENCES TO PATIENT? UNKNOWN EXACT DOSE PATIENT RECEIVED SINCE SPILLED ON FLOOR. WHEN DID THE INCIDENT OCCUR: DURING INFUSION. PATIENT INVOLVEMENT: YES. DEATH/SERIOUS INJURY: NO. HUMAN HARM: NO. DELAY IN THERAPY: NO. MEDICAL INTERVENTION NEEDED: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802628 AP402-01 HCR - MICROBORE YELLOW MARKED WITH NON-VENTED SPIKE ADMINISTRATION SET FPA Q CORE MEDICAL LTD. 622565G 17290109150397

    Patients

    Seq Age Sex Outcome Treatment
    1