BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL ANESTHESIA KIT

    MDR report key: 16582528 · Received March 21, 2023

    Report

    Report Number
    2523676-2023-00072
    Event Type
    Injury
    Date Received
    March 21, 2023
    Report Date
    March 21, 2023
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    OGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE AND/OR LOT NUMBER WERE PROVIDED. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A SAMPLE AND/OR LOT NUMBER. THE ACTUAL DEFECTIVE DEVICE IS VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED PER INTERNATIONAL JOURNAL OF OBSTETRIC ANESTHESIA: SUPERFICIAL ARTERIAL HEMORRHAGE AFTER EPIDURAL CATHETER REMOVAL. THIS CASE PERTAINS TO A PARTURIENT WITH A LARGE-VOLUME SUPERFICIAL ARTERIAL HEMORRHAGE AT THE REMOVAL SITE OF HER EPIDURAL CATHETER, AND THE SUBSEQUENT LOCAL INJECTION OF EPINEPHRINE THAT PROVIDED HEMOSTASIS. A 26-YEAR-OLD FEMALE PRESENTED FOR ANESTHESIA FOR A CESAREAN DELIVERY. WHILE PREVIOUSLY HEALTHY, HER PREGNANCY WAS COMPLICATED BY SEVERE HYPEREMESIS GRAVIDARUM, REQUIRING HOSPITALIZATION AND A LAPAROSCOPIC CHOLECYSTECTOMY AT 25 WEEKS' GESTATIONAL AGE. DESPITE A LACK OF COMPLICATIONS OR EXCESSIVE BLOOD LOSS, HER ABDOMINAL SYMPTOMS CONTINUED, NECESSITATING HOSPITALIZATION UNTIL DELIVERY. AT 32 +1 WEEKS' GESTATIONAL AGE, SHE WAS SCHEDULED FOR A CESAREAN DELIVERY DUE TO PREECLAMPSIA WITH SEVERE FEATURES WHICH INCLUDED HYPERTENSION, LIVER TRANSAMINASES DOUBLE THE NORMAL LIMIT, SEVERE RIGHT UPPER-QUADRANT PAIN, AND HEADACHE. SHE WAS DEEMED ELIGIBLE FOR NEURAXIAL ANESTHESIA AS 12 H HAD ELAPSED SINCE HER LAST PROPHYLACTIC DOSE OF ENOXAPARIN (40 MG SUBCUTANEOUSLY ONCE DAILY). LABORATORY TESTS ON THE MORNING OF DELIVERY SHOWED A HEMOGLOBIN OF 101 G/L AND A PLATELET COUNT OF 195×109/L. COAGULATION STUDIES WERE NOT PERFORMED PRIOR TO DELIVERY GIVEN NO HISTORY OF COAGULOPATHY AND IN ACCORDANCE WITH THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS GUIDELINES FOR OBSTETRIC ANESTHESIA.1 SHE WAS GIVEN A COMBINED SPINAL-EPIDURAL (CSE) ANESTHETIC AFTER A SINGLE MIDLINE INSERTION AT THE L3/4 LEVEL USING A 18-GAUGE TUOHY EPIDURAL NEEDLE AND A 27-GAUGE PENCAN SPINAL NEEDLE (B. BRAUN MEDICAL INC., BETHLEHEM, PA, USA). A 20-GAUGE CLOSED-END, SIDE-FENESTRATED EPIDURAL CATHETER WAS THREADED 5 CM INTO THE EPIDURAL SPACE AND ASPIRATION WAS NEGATIVE FOR BLOOD. THE CESAREAN DELIVERY WAS UNCOMPLICATED, REPORTING AN ESTIMATED BLOOD LOSS OF 550 ML, AND THE EPIDURAL CATHETER WAS REMOVED INTACT WITHOUT ANY BLEEDING. AN HOUR LATER, THE BEDSIDE NURSE NOTED A LARGE AMOUNT OF BLOOD ON THE PATIENT'S BED THAT HAD SOAKED THROUGH THE PATIENT'S ABDOMINAL BINDER, BED PAD, AND SHEET. IMMEDIATE PRESSURE WAS HELD AT THE EPIDURAL SITE AND CONTINUED FOR 10 MIN. THE ANESTHESIOLOGIST ASSESSED THE SITE AND NOTED PULSATILE, BRIGHT-RED BLOOD COMING FROM THE EPIDURAL SITE. IT WAS DECIDED, IN ACCORDANCE WITH A SIMILAR CASE REPORT AND RELATED LITERATURE, 2-3 TO INJECT 3 ML OF 100G/ML EPINEPHRINE AROUND THE EPIDURAL SITE AND PRESSURE WAS SUBSEQUENTLY APPLIED FOR 15 MIN, RESULTING IN COMPLETE HEMOSTASIS.4-5 THE PATIENT DID NOT DEVELOP ANY NEUROLOGICAL SYMPTOMS, TACHYCARDIA, OR HYPERTENSION. QUANTITATIVE BLOOD LOSS FROM THE EPIDURAL SITE WAS APPROXIMATELY 698 ML. BLOOD TESTS SHOWED A HEMOGLOBIN OF 109 G/L, INR 0.8, AND PTT OF 9.4 S. REPEAT TESTS THE FOLLOWING MORNING REVEALED A HEMOGLOBIN OF 82 G/L, WHICH REMAINED STABLE. HER PLATELET COUNT REMAINED IN THE NORMAL RANGE AND SHOWED NO SIGNIFICANT CHANGE (163 TO 172×109/L). HYPEREMESIS, HYPERTENSION, AND ELEVATED LIVER ENZYMES ALL SHOWED IMPROVEMENT, AND WHILE HER FIBRINOGEN LEVEL WAS NOT CHECKED BEFORE THE CSE, THE LEVEL POST BLEEDING WAS 2.73 G/L. SHE WAS DISCHARGED ON POSTOPERATIVE DAY FOUR WITHOUT FURTHER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18130 EPIDURAL ANESTHESIA KIT OGE B. BRAUN MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention