BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CONTINUOUS EPIDURAL TRAY WITH 18G X 3.5" WEISS EPIDURAL NEEDLE

    MDR report key: 5324856 · Received December 23, 2015

    Report

    Report Number
    2243072-2015-00177
    Event Type
    Injury
    Date Received
    December 23, 2015
    Date of Event
    November 29, 2015
    Report Date
    January 27, 2016
    Manufacturer
    BECTON DICKINSON
    Product Code
    CAZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION- BD WAS NOT ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE MEDICAL DEVICE EXPIRATION DATE IS UNKNOWN AS THE LOT NUMBER IS UNKNOWN. MANUFACTURING LOCATION: BD CORPORATE HEADQUARTERS IS USED AS THE MANUFACTURING SITE. THE ACTUAL MANUFACTURING SITE FOR THIS DEVICE, RR DONNELLEY - GLOBAL TURNKEY SOLUTIONS, IS AN OEM. THE DEVICE MANUFACTURE DATE IS UNKNOWN AS THE LOT NUMBER IS UNKNOWN. DEVICE EVALUATION: A SAMPLE IS AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IN LABOR AND DELIVERY HAD AN EPIDURAL PLACED FROM A BD CONTINUOUS EPIDURAL TRAY. THE ANESTHESIOLOGIST REPORTED THE EPIDURAL WAS EASY TO PLACE. A TEST DOSE OF MEDICATION WAS GIVEN WITH NO ISSUES NOTED. A BOLUS DOSE WAS GIVEN APPROXIMATELY 30 MINUTES LATER AND THE RN REPORTED THAT THE PATIENT WAS NOT GETTING ANY RELIEF. INSTEAD OF RE-BOLUSING THE MEDICATION, THE DECISION WAS MADE TO REMOVE THE CATHETER AND PLACE A NEW ONE. UPON REMOVAL, APPROXIMATELY 5CM OF CATHETER WAS MISSING, POSSIBLY SHEARED OFF AT A 45 DEGREE ANGLE AT THE END OF THE CATHETER. AS IT WAS A LARGER PATIENT, A CT SCAN AND MRI WERE PERFORMED TO LOCATE THE TIP OF THE CATHETER BUT WERE UNSUCCESSFUL. AFTER A CONSULT WITH THE NEUROLOGIST, THE DECISION WAS MADE TO LEAVE AS IS, WITH THE POSSIBLE TIP OF THE CATHETER STILL INSIDE THE PATIENT. THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848487 BD CONTINUOUS EPIDURAL TRAY WITH 18G X 3.5" WEISS EPIDURAL NEEDLE EPIDURAL TRAY CAZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention