BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILLINOIS NEEDLE BONE MARROW 15G ADJ LEN

    MDR report key: 2600154 · Received June 6, 2012

    Report

    Report Number
    9680904-2012-00040
    Event Type
    Death
    Date Received
    June 6, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 7, 2012
    Manufacturer
    CAREFUSION
    Product Code
    FSH
    PMA / PMN Number
    K813338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HAS BEEN UPDATED TO REFLECT THAT THE SAMPLE WILL NOT BE RETURNING FOR EVALUATION. CUSTOMER REPORTED THAT THE FACILITY HAS DECIDED NOT TO RETURN THE SAMPLES FOR INVESTIGATION. CUSTOMER AGREED TO ALLOW CAREFUSION TO PERFORM AN ONSITE INVESTIGATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF CAREFUSION'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THIS EVENT INVOLVED TWO NEEDLES, THIS IS REPORT 2 OF 2.

    Additional Manufacturer Narrative · 1

    (B)(4): CAREFUSION PERFORMED AN ONSITE CUSTOMER VISIT AT (B)(6) ON (B)(6) 2012. A DRAPE WAS PLACED ON THE TABLE AND THE SAMPLES WERE PROVIDED BY THE OFFICE MANAGER. TWO SAMPLES OF (B)(4) WERE PROVIDED FOR EVALUATION. THE SAMPLES WILL BE REFERRED TO AS SAMPLE #1 AND SAMPLE #2. MEASUREMENTS OF BOTH NEEDLES WERE MADE USING CAREFUSION CALIPER #(B)(4) FROM THE (B)(6) LAB IN (B)(6). THE SAMPLES WERE HOUSED TOGETHER IN A PLASTIC VIAL WITH A CAP SECURED TO THE TOP. NEITHER DIN HAD A PROTECTOR ON THE NEEDLE. NO OTHER PRODUCT PACKAGING WAS AVAILABLE FOR REVIEW. SAMPLE #1 - DIN NEEDLE HAS LESS ANGULAR DEVIATION FROM ORIGINAL PRODUCTION BETWEEN THE TWO SAMPLES. THERE APPEARED TO BE A SMALL BURR AT THE VERY TIP OF THE STYLET. EVALUATION OF SAMPLE #1 SHOWED ALL APPROPRIATE PLASTIC COMPONENTS. THE TIP CONTAINED THE APPROPRIATE TWO COUNTER GRINDS. THE SIDE WALL GRINDS LOOKED APPROPRIATE. THE CAP WAS SECURELY TIGHTENED TO THE DIN BODY. THE DEPTH GUARD WAS IN ITS FULL RETRACTED POSITION. THE STYLET BEVEL WAS ALIGNED WITHIN THE CANNULA. THERE WAS NO OVERHANG OF THE STYLET WITH RESPECT TO THE CANNULA. THE OUTER DIAMETER OF THE CANNULA WAS MEASURED AND FOUND TO BE (MEASUREMENT TAKEN WITH CALIPER): .0725" (MEASURED AT THE MID-POINT ON THE CANNULA). THE MID-POINT REPRESENTS THE BEST POSITION FROM WHICH TO TAKE THE MEASUREMENT THAT IS REFLECTIVE OF THE ORIGINAL DEVICE SINCE ANY DEVIATION AS A RESULT OF THE BENT WOULD NOT AFFECT THE DIMENSION. THIS RESULT IS WITHIN PRODUCT SPECIFICATIONS. MEASUREMENT OF END OF DEPTH GUARD WITH RESPECT TO THE LOCATION OF THE NEEDLE TIP WAS PERFORMED X 2- #1 - .966", #2 - 1.04" (MEASUREMENTS TAKEN WITH CALIPER). SAMPLE #2 - DIN NEEDLE HAS MORE ANGULAR DEVIATION FROM ORIGINAL PRODUCTION BETWEEN THE TWO SAMPLES. THERE APPEARED TO BE A SMALL "SLIGHT HOOK" AT THE VERY TIP OF THE STYLET . EVALUATION OF SAMPLE #2 SHOWED ALL APPROPRIATE PLASTIC COMPONENTS. THE TIP CONTAINED THE APPROPRIATE TWO COUNTER GRINDS. THE SIDE WALL GRINDS LOOKED APPROPRIATE. THE CAP WAS SECURELY TIGHTENED TO THE DIN BODY. THE DEPTH GUARD WAS IN ITS FULL RETRACTED POSITION. THE STYLET BEVEL WAS ALIGNED WITHIN THE CANNULA. THERE WAS NO OVERHANG OF THE STYLET WITH RESPECT TO THE CANNULA. THE OUTER DIAMETER OF THE CANNULA WAS MEASURED AND FOUND TO BE (MEASUREMENT TAKEN WITH CALIPER): .0720" (MEASURED AT THE MID-POINT ON THE CANNULA). THE MID-POINT REPRESENTS THE BEST POSITION FROM WHICH TO TAKE THE MEASUREMENT THAT IS REFLECTIVE OF THE ORIGINAL DEVICE SINCE ANY DEVIATION AS A RESULT OF THE BENT WOULD NOT AFFECT THE DIMENSION. THIS RESULT IS WITHIN PRODUCT SPECIFICATIONS. MEASUREMENT OF END OF DEPTH GUARD WITH RESPECT TO THE LOCATION OF THE NEEDLE TIP WAS PERFORMED X 2- #1 0.675", #2 - 0.664" (MEASUREMENTS TAKEN WITH CALIPER). A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THIS FAILURE MODE. A POTENTIAL SOURCE FOR THE OBSERVED FAILURE COULD BE THE ENVIRONMENT OF THE CLINICAL SITUATION THAT MAY HAVE CONTRIBUTED TO THE BEND IN THE NEEDLES WHERE THE PARAMEDICS TRIED TO ADVANCE THE NEEDLE WITHIN THE PATIENT WITHOUT THE NEEDLE BEING PERPENDICULAR (90 DEGREES) WITH RESPECT TO THE SURFACE OF THE BONE. THERE IS A SIGNIFICANT DIFFERENCE OF THE STRENGTH OF THE NEEDLE WHEN FORCE IS APPLIED TO WHERE THE NEEDLE IS PERPENDICULAR (APPROXIMATELY 65 POUNDS WITHOUT FAILURE) VS. WHERE FORCE IS APPLIED TO THE NEEDLE AT AN ANGLE (LESS THAN 10 POUNDS WITH DESTRUCTIVE FAILURE). A THOROUGH REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY PLAN INSPECTIONS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE COMPLAINT DATA WAS REVIEWED AND NO SIGNIFICANT TREND WAS NOTICED. THE SUPPLIER WAS NOTIFIED UPON RECEIPT OF THIS REPORT. ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WERE NOTIFIED OF THIS FAILURE MODE IN AN EFFORT TO HEIGHTEN AWARENESS AS WELL.

    Additional Manufacturer Narrative · 1

    (B)(4). IN THE FIRST FOLLOW UP MEDWATCH THE TOP SECTION, USER FACILITY / IMPORTER REPORT NUMBER, WAS INADVERTENTLY FILLED WITH A MANUFACTURER'S REPORT NUMBER.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE DISTRIBUTOR ((B)(4)) PROVIDED THE FOLLOWING INFORMATION: DURING A RESUSCITATION ATTEMPT ON A (B)(6), TWO ATTEMPTS WERE MADE TO ESTABLISH INTRAOSSEOUS ACCESS ON THE PATIENT.  ON BOTH ATTEMPTS, BY TWO DIFFERENT PARAMEDICS, THE BONE MARROW NEEDLES BENT WITH THE TROCAR IN PLACE.  BOTH PARAMEDICS REPORTED THAT THE NEEDLES WERE NOT PENETRATING THE BONE AND AS THE PRESSURE WAS INCREASED, THE CATHETERS BENT.  THIS RESULTED IN NO VASCULAR ACCESS ON THE PATIENT CONTRIBUTING TO AN UNSUCCESSFUL RESUSCITATION ATTEMPT. NO INJURY TO CREW, BUT INABILITY TO APPROPRIATELY TREAT THE PATIENT PROBABLY CONTRIBUTED TO THE PATIENT'S DEATH. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY (B)(6) MANAGER ((B)(6)) ON (B)(6) 2012: THIS WAS A 911 AMBULANCE CALL TO A PRIVATE RESIDENCE. THE NATURE OF THE CALL WAS A (B)(6) NOT BREATHING. THE INITIAL RESPONDING CREW CONSISTED OF A PARAMEDIC AND AN EMERGENCY MEDICAL TECHNICIAN (EMT)-B. THEY WERE BACKED UP BY ANOTHER CREW CONSISTING OF A PARAMEDIC AND AN EMT-I. ON THEIR ARRIVAL THEY FOUND THE CHILD IN CARDIAC ARREST ON THE FLOOR INSIDE THE RESIDENCE. THE HISTORY GIVEN BY THE FATHER INDICATED THE CHILD HAD BEEN ILL WITH GASTROINTESTINAL SYMPTOMS AND WAS SEEN BY HIS PEDIATRICIAN EARLIER IN THE DAY. THE FATHER STATED THE CHILD HAD BEEN IN THE BATHROOM, CAME OUT AND COLLAPSED TO THE FLOOR UNCONSCIOUS. CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED BY THE FATHER. THERE WAS NO FURTHER HISTORY GIVEN. THE MEDICS FOUND THE CHILD TO BE APNEIC AND PULSELESS, INITIAL RHYTHM BEING PULSELESS ELECTRICAL ACTIVITY (PEA). CPR WAS CONTINUED, ALONG WITH BVM (BAG-VALVE-MASK) VENTILATION WITH 100 PERCENT O2. ON "INITIAL PHYSICAL EXAM THE PATIENT PRESENTED WITH SEVERE DEHYDRATION; VERY POOR SKIN TURGOR, DRY/LACKLUSTER EYES, DRY/STICKY ORAL MUCOSA AND NON-VISIBLE, NON-PALPABLE PERIPHERAL VASCULATURE. THIS STAGE OF DEHYDRATION MADE IV ACCESS EXTREMELY DIFFICULT, IF NOT IMPOSSIBLE" (QUOTED PARTS EXCERPTED FROM PARAMEDIC REPORT). THE DECISION WAS MADE TO INITIALLY ATTAIN INTRAOSSEOUS (IO) ACCESS. BOTH MEDICS EXPERIENCED THE SAME FAILURE OF THE IO NEEDLES. THE PATIENT WAS ENDOTRACHEALLY INTUBATED AND RECEIVED EPINEPHRINE AND ATROPINE VIA THE ENDOTRACHEAL TUBE (ETT) ROUTE. IT WAS NOTED ON THE INCIDENT REPORT WRITTEN BY ONE OF THE MEDICS THAT IN HIS IO PREP HE INSPECTED THE NEEDLE AND FOUND IT TO BE INTACT. THE INTENDED INSERTION SITE WAS THE TIBIAL TUBEROSITY ON BOTH PROXIMAL TIBIAS. EXCERPTED FROM THE MEDIC REPORT- "AFTER LOCATING THE TIBIAL TUBEROSITY ON THE PROXIMAL LEFT TIBIA, I MOVED DISTALLY APPROX. 2 CM ON THE FLAT BONY AREA BELOW THE GROWTH PLATE. I THEN CLEANED THE AREA, WITH ALCOHOL AND IODINE, AND ATTEMPTED TO INSERT THE IO NEEDLE. WITH STEADY PRESSURE AND A SLOW TWISTING MOTION, I ATTEMPTED TO INSERT THE IO NEEDLE, HOWEVER BEFORE THE NEEDLE PENETRATED THE BONE, IT BENT OVER WHERE THE NEEDLE MEETS THE PLASTIC HANDLE. SECOND PARAMEDIC THEN ATTEMPTED AN IO INSERTION, IN THE SAME LOCATION ON THE RIGHT LEG, AND HAD THE SAME RESULT OF THE NEEDLE BENDING OVER AT THE HUB." SEVERAL ATTEMPTS WERE MADE FOR PERIPHERAL IV'S, INCLUDING EXTERNAL JUGULARS WITHOUT SUCCESS. (#22 RIGHT HAND, #24 RIGHT FOOT, RIGHT AND LEFT EXTERNAL JUGULAR'S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLINOIS NEEDLE BONE MARROW 15G ADJ LEN TRAY, SURGICAL, NEEDLE FSH CAREFUSION DIN1515X 0000339178

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Death