BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 4-PORT 15 FLTR 2CLV PE ORNG 216CM

    MDR report key: 3543860 · Received November 6, 2013

    Report

    Report Number
    9615050-2013-04653
    Event Type
    Malfunction
    Date Received
    November 6, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 7, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE COMMODITY ON THE INTERNATIONAL LIST NUMBER THAT MALFUNCTIONED IS COMPARABLE TO THE COMMODITY ON THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) AND HAS A 510K OF K982159. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. IT WAS REPORTED THAT WHILE THE NURSE WAS CONNECTING THE CHEMOTHERAPY SOLUTION CONTAINER TO AN UNSPECIFIED CLAVE PORT ON AN UNSPECIFIED THREE WAY CONNECTOR OF THE TUBING SET, THE CLAVE PORT SEPARATED FROM THE THREE WAY CONNECTOR OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. NO INFORMATION WAS PROVIDED IF THE SEPARATION OCCURRED DURING OR PRIOR TO PATIENT USE; HOWEVER, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572875 PLUM 4-PORT 15 FLTR 2CLV PE ORNG 216CM UNK FRN HOSPIRA COSTA RICA LTD. NA 270825H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK