BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CONNECTA

    MDR report key: 3233829 · Received July 16, 2013

    Report

    Report Number
    2243072-2013-00079
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 16, 2013
    Manufacturer
    BD
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED AND IS IN THE PROCESS OF EVAL. ONCE THE EVAL IS COMPLETE, A SUPPLEMENTAL WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THERE WAS LEAKAGE FROM A BROKEN CONNECTA. THE PT DID NOT RECEIVE A FULL DOSE OF THE DRUG DUE TO THE LEAKAGE AND EXPERIENCED LOW BLOOD PRESSURE. ADD'L INFO RECEIVED VIA E-MAIL ON (B)(4) 2013, THE REPORTER STATED THAT THE DRUG THAT WAS BEING ADMINISTERED WAS NORADRENALINE. THE NURSE NOTICED THAT THE CONNECTA WAS LEAKING AND THE PT EXPERIENCED A LOSS OF BLOOD PRESSURE. THE PT'S BLOOD PRESSURE WAS 40/20MHG. THE CONNECTA WAS CHANGED AND THE DRUG WAS RE-ADMINISTERED. THEY ATTEMPTED TO STABILIZE THE PT. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330259 BD CONNECTA 3 WAY STOP COCK FOZ BD 3070340

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention