BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINOCAN SPINAL NEEDLE TRAY

    MDR report key: 1169648 · Received September 18, 2008

    Report

    Report Number
    2523676-2008-00081
    Event Type
    Other
    Date Received
    September 18, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 3, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    BSP
    PMA / PMN Number
    K932569
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DRUG SAMPLE WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED AND A LOT NUMBER WAS NOT PROVIDED. WITHOUT THE SAMPLE OR A LOT NUMBER A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ADDITIONAL PHONE CONVERSATION WITH THE PHYSICIAN INDICATED HE RECOGNIZES, BASED UPON CURRENT LITERATURE, THIS IS A RARE OCCURRENCE POST SPINAL ANESTHESIA AND HAS EXPLAINED THIS TO THE PATIENT. THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED PART NUMBER OR VENDOR DRUG PART NUMBER. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DRUG MANUFACTURER, HOSPIRA INC. FOR FURTHER INVESTIGATION. IF ANY INFORMATION IS RECEIVED FROM HOSPIRA INC. STATING THAT THERE IS AN INHERENT PROBLEM, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE ANESTHESIOLOGIST AT THE USER FACILITY: HERNIA REPAIR PERFORMED IN MAN AS OUTPATIENT, HE HAD SPINAL ANESTHESIA. THAT EVENING HE WAS UNABLE TO MOVE 1 LEG, AND DEVELOPED URINARY RETENTION. HE WAS ADMITTED TO THE HOSPITAL. THE DEVELOPED WEAKNESS IN HIS LEGS...PRESENTLY HE HAS FLACCID PARALYSIS BELOW T5. DIAGNOSED W/MYELOPATHY. SPOKE WITH THE ANESTHESIOLOGIST IN REGARDS TO THE STATUS OF THE PATIENT. HE HAS REPORTED THE PATIENT IS GETTING BETTER. ONE WEEK AFTER THE INCIDENT OCCURRED AN MRI WAS PERFORMED ON THE PATIENT WITH NORMAL RESULTS. AN EMG WAS ALSO PERFORMED WITH NORMAL RESULTS. THE PATIENT HAS BEEN TRANSFERRED TO A REHABILITATION FACILITY AND IS UP AND WALKING AROUND. THE DOCTOR WAS UNABLE TO PROVIDE ANY LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINOCAN SPINAL NEEDLE TRAY SPINOCAN SPINAL TRAY BSP B. BRAUN MEDICAL, INC. S25BK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O