BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD WOUND DRAIN

    MDR report key: 1357791 · Received March 23, 2009

    Report

    Report Number
    1018233-2009-00012
    Event Type
    Injury
    Date Received
    March 23, 2009
    Date of Event
    January 29, 2009
    Report Date
    March 23, 2009
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFORMATION WAS PROVIDED FOR THE COMPANY'S EVALUATION AND THERE WAS NO ALLEGED FAILURE OF THE DEVICE TO PERFORM ITS INTENDED FUNCTION. THIS DRAIN IS RECEIVED FROM A SUPPLIER AND INCOMING QA PERFORMS VISUAL INSPECTION TO VERIFY THE DRAIN ASSEMBLIES ARE FREE OF AIR BUBBLES, NICKS, CUTS, POCK MARKS AND SHORT SHOTS. THEY ALSO PERFORM DIMENSIONAL INSPECTIONS AND AN INSTRON BREAK STRENGTH TEST TO VERIFY TENSILE VALUES. AS A FINISHED GOOD, QA PERFORMS RANDOM VISUAL INSPECTIONS TO VERIFY PRODUCT INTEGRITY. THE TYPE OF SUCTION USED WITH THIS DEVICE IS NOT KNOWN, THEREFORE, INSTRUCTIONS FOR USE COULD NOT BE REVIEWED. IT IS THE RESPONSIBILITY OF THE ATTENDING PHYSICIAN TO TRIM THE DRAIN TO THE DESIRED LENGTH AND TO VERIFY PROPER PLACEMENT. BRAND NAME FROM VOLUNTARY REPORT: HUBLESS SILICONE FLAT DRAIN. COMMON DEVICE NAME FROM VOLUNTARY REPORT: JACKSON-PRATT DRAIN. MODEL # FROM VOLUNTARY REPORT: FLAT DRAIN, SERIAL #: UNK. IMPLANTED DATE FROM VOLUNTARY REPORT: 2009. EXPLANTED DATE FROM VOLUNTARY REPORT: THE SAME DAY. HEALTH PROFESSIONAL: YES. OCCUPATION: BIOMEDICAL ENGINEER. ALSO REPORTED TO: MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WHO HAD SUFFERED HEAD TRAUMA THREE MONTHS EARLIER WAS ADMITTED TO THE HOSPITAL FOR BUR HOLE SUBDURAL DRAINAGE OF A 3CM HEMATOMA UNDER MAC ANESTHESIA. A STANDARD TWIST DRILL WAS USED FIRST AND SUBDURAL FLUID WAS DRAINED WHICH WAS CONNECTED TO A SLUGGISH DRAIN. A STANDARD BUR HOLE WAS CREATED, THE DURA WAS OPENED, MORE FREE FLOW OF SUBDURAL BLOOD WAS ACHIEVED. IRRIGATION WAS DONE AND AN INTERNAL MEMBRANE WAS DIVIDED AND DRAINED OF A SUBSTANTIAL AMOUNT. A SPECIFICALLY DESIGNED JP DRAIN WAS PLACED AND PT WAS SENT TO PACU AT 1139 IN GOOD CONDITION. PT ARRIVED IN PACU AT 1143 WITH PUPILS EQUAL AND REACTIVE TO LIGHT BUT RIGHT PUPIL SLUGGISH, SMILE SYMMETRICAL, TONGUE MIDLINE, ABLE TO RAISE RIGHT ARM WITH NO DRIFT BUT NO LEFT ARM MOVEMENT AND FINGERS WERE CLENCHED. DOCTOR ORDERED NON-CONTRAST CT SCAN WHICH SHOWED THE DRAIN WAS PROJECTING DIRECTLY INTO THE BRAIN PARENCHYMA WITH A SMALL AMOUNT OF HEMORRHAGE AROUND THE DRAIN. THE DRAIN WAS REMOVED AND DISCARDED BY NP. PT WAS TRANSFERRED TO SJVR FOR REHAB IN EARLY 2009, DUE TO PT STILL HAD NO GRIP, NO TRI/BICEP MOVEMENT AND SHOULDER LIFT ONLY ON LEFT SIDE. REQUEST FOR ADDITIONAL INFORMATION AND CLARIFICATION OF INFORMATION WAS DENIED BY THE PT SAFETY OFFICER OF THE REPORTING FACILITY. DATE OF THIS REPORT FROM VOLUNTARY REPORT: 02/27/2009. TEXT FROM VOLUNTARY REPORT: TWO DAYS PRIOR TO ORIGINAL DATE, ADMITTED FOR BUR HOLE DRAINAGE OF 3 CM SUBDURAL HEMATOMA UNDER MAC ANESTHESIA. A STANDARD TWIST DRILL WAS USED FIRST & SUBDURAL FLUID WAS DRAINED WHICH WAS CONNECTED TO A SLUGGISH DRAIN. A STANDARD BUR HOLE WAS CREATED, THE DURA WAS OPENED, MORE FREE FLOW OF SUBDURAL BLOOD WAS ACHIEVED. IRRIGATION WAS DONE & AN INTERNAL MEMBRANE WAS DIVIDED & DRAINED A SUBSTANTIAL AMOUNT, SPECIFICALLY DESIGNED JP DRAIN WAS PLACED, PT TO PACU IN GOOD CONDITIONS. AT 1142 ARRIVED IN PACU, PERL BUT RT SLUGGISH, SMILE SYMMETRICAL, TONGUE MIDLINE, RAISES RIGHT ARM W/NO DRIFT, NO LEFT ARM MOVEMENT, FINGERS CLENCHED. DR ORDERED NON CONTRAST CT WHICH SHOWED THE DRAIN WAS PROJECTING DIRECTLY INTO THE BRAIN PARENCHYMA W/SMALL AMT OF HEMORRHAGE AROUND DRAIN. DRAIN REMOVED BY NP. DRAIN WAS NOT KEPT, DISCARDED. AT 1235 - PASSIVE ROM STARTED ON LEFT ARM, PT STATES "FINGERS, HAND NUMB" & SPEECH WAS THICK. STARTED ON KEPPRA & DEXAMETHASONE. AT 1715, TRANSFERRED TO NICU, NEURO CHECKED SHOWED EXTREME WEAKNESS IN LEFT ARM, LIMITED MOVEMENT, NO GRIP. RIGHT SIDE AND LE EQUAL, FULL ROM, PUPIL EQUAL. ON THE DAY PRIOR TO ORIGINAL DATE REPEAT CT SHOWED MIN EDEMA, SOME BLOOD ALONG THE DRAIN TRACT & MINIMAL MIDLINE SHIFT ON THE LEFT SIDE. PT STILL HAS NO GRIP, NO TRI/BICEP MOVEMENT, SHOULDER LIFT ONLY ON LEFT SIDE. DR MET W/PT & WIFE REGARDING WEAKNESS DUE TO DRAIN & EXPECTED RECOVERY. DISCHARGE TO SJVR IS DECIDED. PT & OT EVALUATION DONE, PT SUGGESTED EDUCATION RE: RIGHT BRAIN INJURY FOR PT & WIFE. STATES LEFT UE IS FLACCID. OT AGREES BUT MARK REHAB POTENTIAL GOOD. ON ORIGINAL DATE SOME ISSUES W/ELEVATED B/P (168/87) LISINOPRIL ORDERED & EFFECTIVE. PT TRANSFERRED TO SJVR AT 1245.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD WOUND DRAIN GBX C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability