BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENCAN

    MDR report key: 6759683 · Received August 2, 2017

    Report

    Report Number
    6759683
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 23, 2017
    Report Date
    July 31, 2017
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS WAS COMPLETED BY THE OBSTETRICS (OB) MANAGER: PATIENT HAD LACK OF ANESTHESIA AFTER SPINAL ANESTHETIC. ANESTHESIOLOGIST FELT HIS TECHNIQUE WAS APPROPRIATE, AND THAT THE MEDICATION IN KIT MAY NOT HAVE BEEN EFFECTIVE. ANOTHER ANESTHESIOLOGIST HAD SIMILAR CONCERNS IN OB RECENTLY. THIS WAS THE PATIENT SAFETY REPORT COMPLETED BY THE OB MANAGER: DR. GAVE PATIENT SPINAL ANESTHESIA FOR HER CESAREAN SECTION (CS). SHE DID NOT GET A BLOCK AND COULD FEEL IT ALL. SHE WAS GIVEN GENERAL ANESTHETIC AFTER DELIVERY PER HER AGREEMENT. THERE IS SUSPICION THAT OTHER SPINAL KITS COULD BE A PROBLEM AS WELL. ANOTHER DR. HAD TROUBLE WITH ONE RECENTLY, BUT WE ARE NOT AWARE OF A LOT NUMBER. SITUATION NEEDS INVESTIGATION. WE WILL NOT CONTACT BRAUN BECAUSE THEY WILL NOT TAKE BACK THE KITS THAT WERE SEQUESTERED. I CAN GET A LOT NUMBER FROM THE TRAY THAT HAD THE INCIDENTS IF NEEDED FROM OUR DISTRIBUTION CENTER. I DID NOT BOTHER TO TAKE THE TIME TO DO THAT BECAUSE IT DOES NOT MAKE A DIFFERENCE. MY DAUGHTER WILL BE COMING HERE TO HAVE A CS AND I WILL ASK TO HAVE THE MEDICATION FOR THE TRAY COME FROM OUR PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541171 PENCAN SPINAL ANESTHESIA KIT CAZ B. BRAUN MEDICAL INC. 333851

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR