BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE PORT MICRO EXTENSION SET - 7" INT

    MDR report key: 1181639 · Received September 30, 2008

    Report

    Report Number
    9613251-2008-00348
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 4, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K953584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BLOOD LOSS. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE DELIVERED AN UNSPECIFIED MEDICATION USING A CARPUJECT SYRINGE VIA THE CLAVE PORT OF THE TUBING SET. FOLLOWING THE MEDICATION DELIVERY, THE TUBING SET WAS FLUSHED WITH AN UNSPECIFIED SOLUTION VIA AN UNSPECIFIED SYRINGE. IT WAS REPORTED THAT AFTER THE SYRINGE WAS DISCONNECTED FROM THE CLAVE PORT, "DROPS" OF BLOOD LEAKED AND IT WAS NOTED THE SILICONE SLEEVE OF THE CLAVE PORT REMAINED DEPRESSED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE PORT MICRO EXTENSION SET - 7" INT 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CARPUJECT SYRINGE: LIST# UNK| UNSPECIFIED SYRINGE: MFR BY BECTON DICKERSON