BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYH,TUOHY,EPINDL,-,20X4.5,25

    MDR report key: 8391538 · Received March 5, 2019

    Report

    Report Number
    9611594-2019-00037
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 13, 2019
    Report Date
    February 15, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSP
    PMA / PMN Number
    K000495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, AA7058K07, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 05-MAR-2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS PERFORMING A BLOOD PATCH YESTERDAY ON A PATIENT WITH A VERY TIGHT EPIDURAL SPACE. THE FIRST SHORTER NEEDLE BECAME BENT AND THERE WERE NO INJURIES FROM THE BENT NEEDLE. THE SECOND LONGER NEEDLE NOT ONLY BENT BUT SHEARED OFF INSIDE THE PATIENT. THE PATIENT WAS OKAY. THE PHYSICIAN PERFORMED "A BIT OF A DISSECTION" TO REMOVE THE BROKEN NEEDLE OUT OF THE EPIDURAL SPACE AND EVENTUALLY REMOVED THE BROKEN SEGMENT OUT OF THE PATIENT'S BODY. ADDITIONAL INFORMATION 18-FEB-2019 STATED THE PROCEDURE TO BE DONE WAS A BLOOD PATCH. THE PHYSICIAN WAS TRYING TO APPROACH THE EPIDURAL SPACE AT A LEVEL CLOSEST TO THE AREA NEEDING THE BLOOD PATCH. IT WAS AT THIS LEVEL THAT THE TWO ATTEMPTS BENT THE NEEDLE. AS THE PHYSICIAN WAS REMOVING THE SECOND NEEDLE, IT BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN NEEDLE SEGMENT BY PERFORMING A SKIN INCISION. THE PHYSICIAN CLOSED THE 1.5CM SKIN INCISION WITH A FEW SUTURES. THE PHYSICIAN THEN ATTEMPTED TO PERFORM THE BLOOD PATCH AT ANOTHER LEVEL AND WAS SUCCESSFUL. THE PATIENT IMMEDIATELY FELT RELIEF FROM HIS SYMPTOMS. THE PATIENT WAS MONITORED IN THE POST-OPERATIVE AREA PER THE USUAL TIME FRAME. THERE WERE NO NEUROLOGICAL DEFICITS NOTED. THE PATIENT WAS STABLE AND DISCHARGED. THE PATIENT RETURNED TO THE FACILITY THE NEXT DAY TO HAVE HIS INTRATHECAL PUMP FILLED, FOR THE FIRST TIME WITH MEDICATION, AND WAS OBSERVED FOR A PERIOD OF HOURS. THERE WERE NO APPARENT ISSUES NOTED IN-REGARDS TO THE BROKEN NEEDLE REMOVED FROM THE PREVIOUS DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185088 HYH,TUOHY,EPINDL,-,20X4.5,25 PAIN MANAGEMENT KITS/TRAYS/NEEDLES BSP AVANOS MEDICAL INC. 18324 AA7058K07

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR