BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 3546323 · Received November 20, 2013

    Report

    Report Number
    1030451-2013-00008
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC.
    Product Code
    LRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER, (B)(6), COMPLAINED THAT A CHLORHEXIDINE AMPULE (CHLORAPREP SEPP) IN THE I.V. START KIT HAD SPLINTERED WHEN BREAKING OPEN. THE INCIDENT OCCURRED ON (B)(6) 2013 BUT THE CUSTOMER REPORT TO FDA WAS DATED ON (B)(4) 2013. (B)(4). MEDICAL ACTION INDUSTRIES INC. ("MAI") MANUFACTURES THE I.V. START KIT THAT CONTAINED THE AMPULE, BUT THE AMPULE IS MADE BY CAREFUSION. THE MEDWATCH DID NOT INDICATE IF THERE WAS AN INJURY RELATED TO THIS REPORT AND HAD ONLY MINIMAL INFO ON THE DESCRIPTION OF THE EVENT OR PROBLEM. WE IMMEDIATELY CONTACTED CAREFUSION, THE CHLORAPREP SEPP MANUFACTURER TO OBTAIN ADDITIONAL INFO AND TO INFORM THEM OF THE MEDWATCH. THE CUSTOMER'S MEDWATCH REPORTER, (B)(6), CONFIRMED THAT THERE WAS NO INJURY INVOLVED. THE SEPP BROKE IN THE ACT OF BEING OPENED, RESULTING IN PRE-ACTIVATION BY THE USER. ALTHOUGH WE HAVE MADE SEVERAL ATTEMPTS, THE CUSTOMER HAS BEEN UNABLE TO CLARIFY EXACTLY WHAT "SPLINTERING" MEANS, SINCE THE GLASS IS SUPPOSED TO BE BROKEN IN ORDER TO RELEASE THE ANTISEPTIC. IT IS UNCLEAR WHETHER OR NOT THE SEPP WAS ACTUALLY DEFECTIVE OR MERELY ACTIVATED PREMATURELY. CAREFUSION OPENED (B)(4) FOR THE ISSUE, AND PROVIDED SHIPPING INSTRUCTIONS TO THE CUSTOMER SO THAT THEY COULD SEND THE SAMPLE DIRECTLY TO CAREFUSION FOR THEIR EVALUATION, WHICH IS STILL IN PROGRESS. CURRENTLY, WE HAVE NO REMAINING INVENTORY OF THE I.V. START KIT COMPLAINT LOT OR OF THE CHLORAPREP SEPP LOTS INVOLVED WITH THIS COMPLAINT AND NO FURTHER COMPLAINTS FOR THIS LOT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602613 NONE NONE LRS MEDICAL ACTION INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1