BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT

    MDR report key: 2423983 · Received January 20, 2012

    Report

    Report Number
    3002769706-2012-00001
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    November 26, 2011
    Report Date
    February 29, 2012
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    FMI
    PMA / PMN Number
    K933939
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RETURNED ADAPTER CAPS AND ADAPTER CAP INSERTS FOUND NO FUNCTIONAL ISSUES WITH EITHER THE ADAPTER CAP OR THE INSERT. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER COMPLAINT, THE ROOT CAUSE OF THE INCIDENT WAS DUE TO ACCIDENTAL CUSTOMER ERROR THAT RESULTED IN THE CUSTOMER'S FINGER SLIPPING INSIDE THE ADAPTER CAP AND ADAPTER CAP INSERT AND BEING STUCK BY THE BLOOD COLLECTION SET NEEDLE. THE ADAPTER CAP AND INSERT ARE BIOMERIEUX PARTS AND ARE DESIGNED TO BE COMPATIBLE WITH BLOOD COLLECTION SETS THAT ARE MADE BY OTHER MANUFACTURERS. A REVIEW OF BD'S PACKAGE INSERT INCLUDES A GENERAL PRECAUTION STATEMENT REGARDING THE USE OF SHARPS: HANDLE ALL BIOLOGIC SAMPLES AND BLOOD COLLECTION "SHARPS" (LANCETS, NEEDLES, LUER ADAPTERS, AND BLOOD COLLECTION SETS) IN ACCORDANCE WITH THE POLICIES AND PROCEDURES OF YOUR FACILITY. OBTAIN APPROPRIATE MEDICAL ATTENTION IN THE EVENT OF ANY EXPOSURE TO BIOLOGIC SAMPLES (E.G., THROUGH A PUNCTURE INJURY) SINCE SAMPLES MAY TRANSMIT VIRAL HEPATITIS, HIV (AIDS), OR OTHER INFECTIOUS DISEASES. UTILIZE ANY SAFETY ENGINEERED FEATURE IF THE BLOOD COLLECTION DEVICE PROVIDES ONE. THE BACT/ALERT BLOOD COLLECTION ADAPTER CAP IS A PLASTIC CAP THAT FITS OVER BLOOD CULTURE BOTTLES AND IS USED IN CONJUNCTION WITH A BLOOD COLLECTION SET. BIOMERIEUX DOES NOT PROVIDE OR MANUFACTURE THE BLOOD COLLECTION SET AND THIS MATERIAL IS LISTED IN THE "MATERIALS REQUIRED BUT NOT PROVIDED" SECTION. THE ADAPTER CAP PACKAGE INSERT INSTRUCTS THE USER TO "REFER TO YOUR FACILITY'S APPROVED PROCEDURES FOR USE OF THE BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT." THE BIOMERIEUX ADAPTER CAP PACKAGE INSERT ALSO CONTAINS STEP BY STEP INSTRUCTIONS FOR THE TEST PROCEDURE ON HOW TO USE THE ADAPTER CAP. STEPS 1-6 PROVIDE INSTRUCTIONS ON HOW TO USE THE ADAPTER CAP WITH BACT/ALERT CULTURE BOTTLES, AND A NOTE FOLLOWS THESE STEPS THAT STATES "IF ADDITIONAL BLOOD IS REQUIRED FOR OTHER TESTS, PLACE THE ADAPTER INSERT INTO THE ADAPTER CAP AND LOCK INTO PLACE. THIS MAKES THE CAP COMPATIBLE WITH VACUUM COLLECTION TUBES." THE LAST STEP IN THE TEST PROCEDURE SECTION STATES "AFTER BLOOD COLLECTION IS COMPLETE, REMOVE THE ADAPTER CAP FROM THE CULTURE BOTTLE AND THEN REMOVE THE NEEDLE FROM THE PATIENT'S VEIN." THE STEP-BY-STEP INSTRUCTIONS PROVIDE CLEAR INSTRUCTIONS FOR THE USER TO FOLLOW. THE ADAPTER INSERT IS INTENDED TO BE USED AT THE LAST STAGES OF BLOOD COLLECTION IF ADDITIONAL BLOOD IS NEEDED TO BE DRAWN INTO VACUUM COLLECTION TUBES. TO FURTHER CLARIFY THE ADAPTER INSERT SHOULD BE USED AT THE LAST STEP, ADDITIONAL VERBIAGE WILL BE ADDED TO THE ADAPTER CAP PACKAGE INSERT TO INSTRUCT USERS NOT TO REMOVE THE INSERT FROM THE CAP AND TO DISCARD THE BLOOD COLLECTION ADAPTER CAP AND INSERT AFTER USE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A TECHNICIAN STUCK HIMSELF ON THE NEEDLE INSIDE THE BACT/ALERT ADAPTER CAP (PN 279012) WHILE TRYING TO GET THE INSERT OUT OF THE ADAPTER TO DRAW BLOOD CULTURES. THE TECHNICIAN WAS IN THE PROCESS OF INSERTING A VACUUM CONTAINER TUBE WHEN THEIR HAND SLIPPED INTO THE ADAPTER CAP CAUSING THEIR FINGER TO BE STUCK BY THE SHEATHED NEEDLE. THE NEEDLE IS USED TO PIERCE THE SEPTUM IN BACT/ALERT BLOOD CULTURE BOTTLES. THERE IS A THIN RUBBER SHEATH/COVER THAT RETRACTS WHEN THE ADAPTER CAP IS PLACED ON THE CULTURE BOTTLE. THE BACT/ALERT ADAPTER CAP IS USED TO FACILITATE THE FILLING OF BLOOD INTO A BACT/ALERT BLOOD CULTURE BOTTLE. THE BACT/ALERT BLOOD COLLECTION ADAPTER INSERT IS USED FOR POSITIONING A TRANSFER NEEDLE TO FACILITATE BLOOD COLLECTION INTO BLOOD COLLECTION TUBES. THE ADAPTER CAP PACKAGE INSERT RECOMMENDS THE TECHNICIAN TO FOLLOW THE FACILITY'S APPROVED PROCEDURES FOR USE FOR THE BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT. THE TEST PROCEDURE STATES TO PLACE THE ADAPTER CAP ON BACT/ALERT BLOOD CULTURE BOTTLES FIRST, AND, IF ADDITIONAL BLOOD IS REQUIRED FOR OTHER TESTS, TO INSERT THE ADAPTER INSERT, LOCK INTO PLACE AND NOW THE APPARATUS IS COMPATIBLE WITH VACUUM COLLECTION TUBES. AN INVESTIGATION HAS BEEN OPENED FOR THIS INCIDENCE. THE ORIGINAL KIT WAS DISPOSED AND NOT AVAILABLE FOR INVESTIGATION, BUT THE CUSTOMER DID SEND SIMILAR KITS TO BE INSPECTED. THE CUSTOMER DOES NOT KNOW THE LOT NUMBER AS THE ADAPTER CAPS ARE ADDED TO A COMMUNAL BIN. THE EVENT IS REPORTABLE TO THE FDA AS AN ADVERSE EVENT BECAUSE THE CUSTOMER HAD TO SEEK MEDICAL TREATMENT TO DETERMINE EXPOSURE TO THE ADAPTER CAP NEEDLE AND THE CUSTOMER WOULD NOT PROVIDE ANY ADDITIONAL TREATMENT WAS ADMINISTERED OR THE RESULTS OF ANY TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT FMI BIOMERIEUX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention