BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMC HAND STRIPPER

    MDR report key: 2258925 · Received August 18, 2011

    Report

    Report Number
    1118880-2011-00010
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    KSD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - BASED UPON EVAL OF USER FACILITY INFO; BASED UPON RETURN SAMPLE EVAL. EXAMINATION OF THE RETURNED SAMPLE DETERMINED THAT THERE WERE NO DEFECTS OR ANOMALIES AND THE DEVICE OPERATED PROPERLY W/O CREATING ANY DAMAGE TO TUBING DURING TESTING. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. IN ADDITION, THERE ARE NO PREVIOUS REPORTS OF A SIMILAR OCCURRENCE FOR ANY LOT OF THIS PRODUCT FAMILY. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITELY DETERMINED BASED UPON THE AVAILABLE INFO, THE EVENT DESCRIPTION IS MOST CONSISTENT WITH THE TUBING HAVING BEEN DAMAGED AS A RESULT OF USER ERROR. THE TERUMO MULTI-FUNCTION HAND STRIPPER DEVICE IS A CLASS I EXEMPT DEVICE (KSD). ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND F/U. (B)(4).

    Description of Event or Problem · 1

    A BLOOD COLLECTION CENTER REPORTED THAT A STAFF MEMBER WAS SPRAYED WITH BLOOD WHILE EVALUATING A HAND-STRIPPER DEVICE. THE FOLLOWING INFO WAS PROVIDED: "CLASSROOM" STYLE TRAINING WAS BEING HELD TO DEMONSTRATE THE USE OF THE TERUMO MULTI-FUNCTION HAND STRIPPER DEVICE; STAFF MEMBERS WERE GIVEN THE OPPORTUNITY TO "TEST" THE DEVICE ON TUBING CONNECTED TO AN EMPTY, UN-USED BLOOD BAG; UNBEKNOWNST TO THE PERSON CONDUCTING THE DEMONSTRATION, A STAFF MEMBER ATTEMPTED TO USE THE DEVICE ON A UNIT THAT CONTAINED A RECENT DONATION; THE TUBING WAS CUT / DAMAGED SOMEHOW WHEN THE STAFF MEMBER ATTEMPTED TO STRIP A SECTION OF BLOOD BAG TUBING, WHICH RESULTED IN BLOOD SPRAYING INTO THE STAFF MEMBER'S FACE AND MOUTH; NO FACE PROTECTION WAS BEING WORN; MANAGEMENT STAFF CONFIRMED THAT THE BLOOD IN THE TUBING WAS FROM A REPEAT DONOR WITH NO KNOWN INFECTIOUS DISEASES; AND THEREFORE, NO MEDICAL TREATMENT WAS DEEMED NECESSARY FOR THE STAFF MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMC HAND STRIPPER KSD TERUMO MEDICAL CORPORATION NA 110323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA