BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T HOLDER DEVICE WITH MULTI-SAMPLE MALE LUER ADAPTER

    MDR report key: 1978105 · Received February 1, 2011

    Report

    Report Number
    1978105
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 1, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RN WAS ATTEMPTING TO DRAW BLOOD FROM A PATIENT'S CENTRAL LINE. THE HUB WAS SCRUBBED WITH CHLORAPREP AND THE CLAVE WAS ACCESSED WITH THE SAF-T HOLDER DEVICE. THE RN THEN INSERTED THE RUBBER TOPPED GLASS TUBE AND DEPRESSED IT SO THAT THE SHEATHED NEEDLE INSIDE THE HOLDER ENTERED THE RUBBER STOPPER. HOWEVER, NO BLOOD ENTERED THE TUBE AS EXPECTED. THE RN CHECKED THE LINE AND THE EQUIPMENT. UPON CLOSER INSPECTION, THE RN NOTED WHAT APPEARED TO BE CRACKING ON THE LUER OF THE SAF-T HOLDER. SHE THEN REMOVED THE SAF-T HOLDER FROM THE CLAVE BY UNSCREWING IT. ONCE REMOVED, THE RN NOTED THAT THE MALE ADAPTER OF THE SAF-T HOLDER HAD CRACKED OFF. CLOSER INSPECTION OF THE CLAVE REVEALED THAT THE MALE ADAPTER PIECE THAT HAD BROKEN OFF OF THE SAF-T HOLDER REMAINED INSIDE THE CLAVE. THE RN CLAMPED THE LINE TEMPORARILY AND REPLACED THE BLUE CLAVE. SHE THEN OBTAINED ANOTHER SAF-T HOLDER (SAME LOT NUMBER) AND BLOOD TUBE & WAS ABLE TO SUCCESSFULLY DRAW THE BLOOD SAMPLE FROM THE LINE. OF NOTE, WHEN THE RN ENGAGED THE SAF-T HOLDER ONTO THE CLAVE INITIALLY, SHE REPORTS THAT SHE DID NOT USE UNUSUAL FORCE OR TORQUE & THAT THE DEVICE WAS EASY TO APPLY/ENGAGE. THERE WERE NO OBVIOUS CRACKS OR DEFECTS IN THE DEVICE PRIOR TO USE AND THE RN DID NOT HEAR A CRACKING SOUND WHEN SHE ENGAGED THE LUER. THE RN'S ONLY INDICATION THAT SOMETHING WAS NOT WORKING WAS THAT BLOOD DID NOT FILL INTO THE TUBE AS EXPECTED. STAFF SUSPECT THAT THE REASON BLOOD DID NOT FILL INTO THE TUBE WAS BECAUSE THE VACUUM IN THE TUBE WAS INTERRUPTED BY AIR CAUSED BY THE MALE END OF THE SAF-T HOLDER CRACKING OFF INSIDE THE CLAVE. THE PATIENT WAS NOT HARMED AND CARE WAS NOT DELAYED AS A RESULT OF THIS EVENT. STAFF HAS NOT HAD ANY OTHER DEVICES WITH THIS PROBLEM.======================MANUFACTURER RESPONSE FOR SAF-T HOLDER, SAF-T HOLDER DEVICE WITH MULTI-SAMPLE MALE LUER ADAPTER======================A MESSAGE WAS LEFT WITH SMITH MEDICAL'S CUSTOMER COMPLAINT LINE. WE ARE AWAITING THE MANUFACTURER'S INSTRUCTION FOR RETURNING THE DEVICE SO THAT THEY MAY INVESTIGATE AND ANALYZE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T HOLDER DEVICE WITH MULTI-SAMPLE MALE LUER ADAPTER SAF-T HOLDER JKA SMITHS MEDICAL * 1901767

    Patients

    Seq Age Sex Outcome Treatment
    1 *