BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B. BRAUN

    MDR report key: 1882010 · Received October 19, 2010

    Report

    Report Number
    MW5017890
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 19, 2010
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SEEN IN THE OUTPATIENT PAIN CENTER. SHE WAS TO HAVE AN EPIDURAL STEROID INJECTION. AFTER THE NEEDLE WAS INSERTED, THE PHYSICIAN NOTED A FOREIGN BODY IN THE BARREL OF THE SYRINGE. HE STATED THE OBJECT LOOKED LIKE A PIECE OF BROWN PAPER. HE STOPPED THE PROCEDURE AND SENT THE OBJECT FOR CULTURE ANALYSIS AS HE WAS CONCERNED WITH THE STERILITY OF THE MATERIAL. CULTURE RESULTS WERE NEGATIVE. HE BELIEVES THAT THE ITEM COULD HAVE BEEN INJECTED HAD HE HAD A LARGER NEEDLE ATTACHED. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: STEROID INJECTION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B. BRAUN PERIFIX SINGLE DOSE EPIDURAL ANESTHESIA TRAY CAZ B. BRAUN MEDICAL INC. 18 GA 61108255

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR