BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENCAN

    MDR report key: 305498 · Received November 17, 2000

    Report

    Report Number
    305498
    Event Type
    Other
    Date Received
    November 17, 2000
    Date of Event
    October 11, 2000
    Report Date
    October 20, 2000
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    MEDWATCH REPORT #070022-2000-0012 RECEIVED FROM THE USER FACILITY STATES THE FOLLOWING: "SPINAL NEEDLE BROKE INSIDE PT'S BACK; ABOUT 1 1/2 INCHES REMAINED UNDER SKIN. THIS OCCURRED WHILE PT BEING GIVEN SPINAL ANESTHESIA IN PREPARATION FOR A CESAREAN SECTION." THE INITIAL INFORMATION RECEIVED VIA TELEPHONE FROM THE USER FACILITY, INDICATES THAT THE PT WAS OBESE. THE PT HAD NO ADVERSE REACTIONS AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENCAN PENCAN SPINAL TRAY CAZ B. BRAUN MEDICAL, INC. P25BK 60070187

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other