BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH T-CONN. SL

    MDR report key: 3099344 · Received May 2, 2013

    Report

    Report Number
    9613251-2013-00125
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 4, 2013
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. D8, D9: THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. THE CATALOGS NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K05722. 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 THE SPIN-LOC MALE ADAPTER WAS CRACKED; SUBSEQUENTLY, A LEAK WAS NOTED. THE SPIN-LOC MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED PATIENT IV ACCESS SITE AND WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM A CRACK AT AN UNSPECIFIED LOCATION IN THE SPIN-LOC MALE ADAPTER OF THE TUBING SET. THE CUSTOMER CONTACT REPORTED THAT THE PATIENT'S IV ACCESS SITE WAS EITHER LOST OR PARTIALLY BLOCKED. THE TUBING SET WAS REPLACED. THE CUSTOMER CONTACT INDICATED THAT THE TUBING SET WAS BEING USED AS DEEP LINE AND REPORTED AS CRUCIAL TO THE PATIENT. NO SPECIFIC DETAILS WERE PROVIDED. ALTHOUGH THERE WAS POTENTIAL FOR SERIOUS INJURY, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191628 EXTENSION SET WITH T-CONN. SL UNK FPA HOSPIRA, LTD NA 21190NY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED IV CATHETER: LIST #UNK, LOT #UNK