BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFIX CONTINUOUS EPIDURAL TRAYS

    MDR report key: 3102088 · Received April 23, 2013

    Report

    Report Number
    2523676-2013-00102
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K840179
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED CATALOG NUMBER, FINISHED GOOD LOT NUMBER, OR EVALUATED CATHETER LOTS. NO ADVERSE TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS. BATCH RECORD REVIEW OF THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER FOR FURTHER EVALUATION. A FOLLOW UP REPORT WILL BE FILED IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: DATE OF OCCURRENCE: LAST 2 WEEKS (7 INCIDENTS ON 3 PATIENTS TOTAL - 2 THIS WEEK, 1 LAST WEEK INVOLVING 4 CATHETERS AND 1 PATIENT); HAS BEEN OCCURRING OVER PAST 1 MONTH (8-10 INCIDENTS). EVENT: EPIDURAL PLACEMENT IN BLOOD VESSEL OR MIGRATION OF CATHETER INTO BLOOD VESSEL AFTER SEVERAL HOURS IN THE EPIDURAL SPACE IN LABORING WOMEN. NO DIFFICULTY WITH INSERTION OR OVERT ANATOMICAL ABNORMALITIES WITH PATIENT. DETAILS RE: INCIDENT FROM LAST WEEK - 1 PATIENT - HAD TO PERFORM EPIDURAL INSERTION 4 TIMES AT DIFFERENT LEVELS - AFTER 3 INSERTIONS UPON ASPIRATION ALL CATHETERS WERE IN BLOOD VESSELS AS EVIDENCED BY BLOOD RETURN, 4TH INSERTION WAS SUCCESSFUL BUT AFTER SEVERAL HOURS, EPIDURAL INFUSION WAS NOTED TO NOT BE INFUSING, UPON ASPIRATION, NOTED BLOOD IN CATHETER. DOCTOR NOTES HE HAS BEEN WORKING SINCE 1986, AND HAS BEEN PLACING CATHETERS IN APPROXIMATELY 5 PATIENTS PER DAY FROM (B)(6), AND HAS JUST NOTICED THIS OCCURRING OVER THE LAST MONTH, DEFINITELY THE SAME LOT NUMBER HAS BEEN USED OVER THE PAST 2 WEEKS. NO SAMPLE OF CATHETER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173992 PERFIX CONTINUOUS EPIDURAL TRAYS CE17TK CONT EPIDURAL TUOHY CAZ B. BRAUN MEDICAL, INC. CE17TK 0061291682

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other