BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® CUSTOM EPIDURAL SET

    MDR report key: 6714667 · Received July 14, 2017

    Report

    Report Number
    3012307300-2017-01482
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    April 10, 2017
    Report Date
    July 14, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL CATALOG NUMBER - 100/395/560. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER OF A PORTEX® CUSTOM EPIDURAL SET SEVERED, AND 1.7CM OF THE CATHETER WAS MISSING. THE PATIENT WAS IN FOR REPAIR OF INCISIONAL HERNIA SURGERY AND CHOLECYSTECTOMY. THE PATIENT HAD A PREVIOUS FAILED EPIDURAL, AND A REGIONAL ANESTHESIA (EPIDURAL AND SPINAL). "T-10 MULTIPLE BONY OBSTRUCTIONS, AND ONCE LOR TO SALINE, SO TRIED TO PASS CATHETER". IT WAS NOTED THAT IT DID NOT GO EASILY, SO THE OPERATOR TOOK THE NEEDLE AND THE CATHETER OUT TOGETHER. "T-11 BONY OBSTRUCTIONS, AND SPINAL L4-5 BONY STRUCTURES", THE PROCEDURE WAS ABANDONED. AT THE END OF THE PROCEDURE, THE STAFF REALIZED THAT 1.7CM OF THE EPIDURAL CATHETER WAS MISSING. THE STAFF COULD NOT FIND THE TIP OUTSIDE OF THE PATIENT. THE PATIENT HAD AN ULTRASOUND SCAN OF THEIR BACK AND THE TIP STILL COULD NOT BE FOUND. THE PATIENT THEN HAD A CT SCAN, WHERE NO EVIDENCE OF A FOREIGN BODY WAS FOUND. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494622 PORTEX® CUSTOM EPIDURAL SET EPIDURAL ANESTHESIA KIT OGE SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1