BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN®

    MDR report key: 16713286 · Received April 11, 2023

    Report

    Report Number
    9610825-2023-00136
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    January 18, 2023
    Report Date
    August 31, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MIA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). THE COMPLAINT IS UNDER INVESTIGATION. A FOLLOW-UP WILL BE PROVIDED AFTER THE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER: (B)(4). REVIEWED THE DHR FOR THE BATCH NUMBER: 22F25G8218, NO ABNORMALITY WAS OBSERVED DURING IN-PROCESS INSPECTION. NO SAMPLE AND NO PICTURE WAS PROVIDED FOR FURTHER INVESTIGATION. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN COLOMBIA. "BROKEN DEVICE." . ACCORDING TO THE CUSTOMER: "FEMALE PATIENT 27 YEARS OLD, OBESE 110KG, HEIGHT 163 CM, DURING APPLICATION OF SPINAL ANESTHESIA SPINAL NEEDLE FRACTURE AND REMAINS LODGED IN DEEP SUBCUTANEOUS TISSUE, SCHEDULED SURGERY IS POSTPONED; ABDOMINAL HYSTERECTOMY AND PROCEED TO REQUEST SIMPLE TAC OF LUMBAR SPINE AND NEUROSURGEON ON DUTY CONSULTATION. AFTER ASEPSIS OF THE LUMBAR REGION, WITH PATIENT IN PRONE POSITION AND UNDER FLUOROSCOPIC VISION, FOREIGN BODY LOCATION IS PERFORMED IN L2-L3. SKIN INCISION IS MADE. SUBCUTANEOUS DISSECTION IS PERFORMED UNTIL FASCIA IS REACHED. FASCIA IS INCISED. SPINOUS AND LAMINAE OF THE LEFT SIDE ARE DISSECTED. THE FOREIGN BODY IS LOCATED AND PASSES INTO THE LUMBAR CANAL. IT IS SLOWLY REMOVED WITHOUT OBSERVING CEREBROSPINAL FLUID OUTFLOW. FOREIGN BODY IS DELIVERED (NEEDLE OF APPROXIMATELY 40 MM IN LENGTH). FASCIA AND SUBCUTANEOUS CELL IS SUTURED. 3-0 PROLENE SKIN SUTURE IS PERFORMED.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397057 PENCAN® SPINAL NEEDLE MIA B. BRAUN MELSUNGEN AG 22F25G8218

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention