BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSAFE

    MDR report key: 939725 · Received November 5, 2007

    Report

    Report Number
    2528905-2007-00001
    Event Type
    Malfunction
    Date Received
    November 5, 2007
    Date of Event
    October 5, 2007
    Report Date
    November 2, 2007
    Manufacturer
    SAFE-TEC CLINICAL PRODUCTS, INC.
    Product Code
    GIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION THROUGH VISUAL INSPECTION OF UNITS RETURNED BY MFR TO SAFE-TEC CONFIRMED THAT UNITS WERE 15UL TUBES PACKAGED WITH MFR-SPECIFIC LABELS INDICATING 40UL TUBES. SAFE-TEC CONDUCTED AN INTERNAL INVESTIGATION INVOLVING THE SUBCONTRACTED MFR. PROCESS FLOW IS AS FOLLOWS: SENT TO SAFE-TEC FOR INSPECTION, AND THEN SAFE-TEC SENDS THE TUBES TO JORSOW FOR REPACKAGING INTO SMALLER QUANTITIES PER CUSTOMER REQUIREMENTS. NEW LABELS ARE APPLIED PER CUSTOMER REQUIREMENTS. UPON REVIEW OF PROCESSES AND PROCEDURES IN AN INTERNAL INVESTIGATION IT WAS DETERMINED THAT THE PROBLEM MOST LIKELY WAS CAUSED AT THE RE-PACKAGER, JORSOW, INC. INVESTIGATION DETERMINED THAT 15UL TUBES IN AN OPEN BULK BAG WERE RETURNED TO INVENTORY FROM THE PACKAGING LINE AND MISTAKENLY MIXED WITH 40UL INVENTORY. JORSOW HAS COMPLETED A 100% INSPECTION OF SAFE-TEC INVENTORY AND CONFIRMED THAT THE PROBLEM WAS LIMITED TO ONE LOT OF 40UL TUBES. ALL AFFECTED INVENTORY WAS SOLD EXCLUSIVELY TO MFR, HAS THEIR UNIQUE LABEL ON EACH PACKAGE, AND ALL AFFECTED INVENTORY WAS ACCOUNTED FOR. LOTS PRODUCED BEFORE AND AFTER THE AFFECTED LOT WERE INSPECTED AT TRINITY AND WERE GOOD. CORRECTIVE ACTIONS HAVE BEEN INITIATED AT SAFE-TEC AND AT JORSOW TO PREVENT A REOCCURRENCE OF THE PROBLEM, INCLUDING PROCEDURE CHANGES FOR LINE CLEARANCE AND RETURN TO INVENTORY. SAFE-TEC IS CONDUCTING A VENDOR INSPECTION OF JORSOW TO CONFIRM THEIR CORRECTIVE ACTIONS. MFR HAS ACCEPTED SAFE-TEC'S INVESTIGATION AND CORRECTIVE ACTION PLAN. ALL AFFECTED INVENTORY HAS BEEN ACCOUNTED FOR, SO NO RECALL OR FIELD CORRECTIVE ACTION BY SAFE-TEC IS NECESSARY. UNLESS ADD'L DATA IS OBTAINED, THIS INVESTIGATION IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    SAFE-TEC PRODUCES MICROSAFE CAPILLARY TUBES USED IN VARIOUS BLOOD TEST KITS. ON 10/05/2007, A CUSTOMER, WHICH IS A DISTRIBUTOR IN ANOTHER COUNTRY, REPORTED THAT ONE OF THEIR CUSTOMER IN A FOREIGN COUNTRY, WHICH USES THE CAPILLARY TUBES IN THEIR TEST KITS, RECEIVED THE WRONG SIZE TUBES IN A SHIPMENT. MFR IS SUPPLIED 40UL TUBES IN PACKAGES OF 25 EACH WITH THEIR UNIQUE LABEL ON EACH PACKAGE. MFR NOTIFIED OTHER MFR THAT THEY FOUND SEVERAL PACKAGES OF 15UL TUBES MIXED IN WITH 40UL TUBES IN THEIR INVENTORY. MFR INDICATED THAT BAGS WERE MISLABELED, ONE WAS RETURNED FROM A LABORATORY IN US (IDENTITY UNK) AND THE REST OF BAGS WERE FOUND IN A 100% INVENTORY CHECK. ONLY ONE LOT OF 40UL TUBES WAS AFFECTED. TUBES ARE USED IN HIV TEST KITS SOLD BY MFR INTO THE US. ACCORDING TO MFR, THEY NOTIFIED THE FDA OF THE IMPACT ON THEIR TEST KIT AND ALSO INITIATED A PRODUCT RECALL. THEY ARE TREATING THE CAPILLARY TUBES AS COMPONENTS IN THEIR TEST KITS. HOWEVER, THE DEVICES CAN BE CONSIDERED TO BE FINISHED DEVICES OF SAFE-TEC, WHICH IS WHY THIS REPORT HAS BEEN PREPARED. SAFE-TEC HAS NO INFO THAT ANY PATIENTS WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSAFE CAPILLARY BLOOD COLLECTION TUBE GIO SAFE-TEC CLINICAL PRODUCTS, INC. 1646

    Patients

    Seq Age Sex Outcome Treatment
    1 YR