BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP PRIMARY PLUM PREPIERCED Y

    MDR report key: 3096709 · Received April 25, 2013

    Report

    Report Number
    9615050-2013-00942
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 28, 2013
    Manufacturer
    HOSPIRA HOLDINGS DE 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 CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED DISCONNECTION WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) AND HAS A 510K OF K081412. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION. THE SECURE LOCK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO A FEMALE ADAPTER OF AN UNSPECIFIED CENTRAL VENOUS ACCESS STOPCOCK AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE SECURE LOCK MALE ADAPTER DISCONNECTED FROM THE FEMALE ADAPTER OF THE CENTRAL VENOUS ACCESS STOPCOCK. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179422 NDEHP PRIMARY PLUM PREPIERCED Y UNK FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED CENTRAL VENOUS ACCESS STOPCOCK:| MFR UNK