BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS

    MDR report key: 10268420 · Received July 13, 2020

    Report

    Report Number
    3012307300-2020-07239
    Event Type
    Injury
    Date Received
    July 13, 2020
    Date of Event
    March 1, 2020
    Report Date
    September 2, 2020
    Product Code
    CAZ
    UDI-DI
    30351688081661
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLE HAS BEEN PROVIDED FOR INVESTIGATION. THE CUSTOMER PROVIDED THE PHOTOS FOR EVALUATION (SEE ATTACHED IN (B)(4). REVIEW OF THE FIRST PHOTO FOUND A LABEL PART NUMBER A4134-17 LOT # 3922278. EVALUATION OF THE SECOND PHOTO FOUND A STRETCHED FRAGMENT OF THE CATHETER AND A THREAD ASSIST DEVICE. REVIEW OF THE THIRD PHOTO FOUND A FRAGMENT OF THE CATHETER AT THE DISTAL END, STRETCHED AND DISTORTED. THE TIP OF THE CATHETER WAS OBSERVED TO BE MISSING, WHICH CONFIRMS THE REPORTED BY THE CUSTOMER ALLEGATION. PER COMPLAINT INFORMATION, THE CUSTOMER PULLED THE CATHETER WHILE STILL INSIDE THE TOUHY NEEDLE. INSTRUCTIONS FOR USE (CLA617, REV. 000) INSTRUCT THE USER TO WITHDRAW THE NEEDLE OVER THE CATHETER. THE IFU CLEARLY CAUTIONS THE CLINICIAN TO "NEVER WITHDRAW THE CATHETER BACK THROUGH THE EPIDURAL NEEDLE AS THIS MAY CAUSE THE CATHETER TO KINK OR SHEAR". BASED ON THE AVAILABLE INFORMATION FROM THE COMPLAINT, THE PROBLEM SOURCE IS MOST LIKELY ASSOCIATED WITH PRODUCT APPLICATION BY THE CLINICIAN. ONE YEAR COMPLAINT HISTORY REVIEW SINCE JUNE 2019 FOUND NO TRENDS RELEVANT TO THIS PRODUCT AND CATEGORY. NO FURTHER ACTION WILL BE CONDUCTED AT THIS TIME. COMPLAINT INFORMATION WILL CONTINUE TO BE MONITORED FOR ANY NEW INFORMATION OR ADVERSE TRENDS AND TAKE FURTHER ACTIONS ACCORDINGLY.

    Description of Event or Problem · 0

    PER MEDWATCH.ANESTHESIOLOGY ATTEMPTED TO PLACE A L3 AND L4 EPIDURAL ON ONE ATTEMPT THERE WAS A LOSS OF RESISTANCE WHEN THE CATHETER WAS THREAD. THE ANESTHESIOLOGY FELT SOME RESISTANCE SO THEY STOPPED. THE PATIENT REPORTED A TRANSIENT RIGHT SIDE PARENTHESIS SO THEY DECIDED TO PULL THE CATHETER AND REPOSITION. THE CATHETER WAS AT 12CM AT THE TOUHY NEEDLE HUB. WHEN THE ANESTHESIOLOGY PULL THE CATHETER THEY FELT A SUDDEN SNAP. THE CATHETER BROKE OFF INSIDE THE PATIENT. THE NEEDLE SKIN WAS INSPECTED AND THE COILED WIRE WAS STILL IN THE PATIENT, IT WAS PULLED AND REMOVED. WHEN THE CATHETER WAS INSPECTED IT WAS FOUND BROKEN AT APPX 4CM. (B)(6) 2020, ADDITIONAL INFORMATION RECEIVED CUSTOMER STATED THAT THE PATIENT WAS ASSESSED BY NEUROSURGERY PRIOR TO THEIR DISCHARGE FROM THE HOSPITAL IN LATE (B)(6) 2020. THEY WERE ENCOURAGED TO FOLLOW UP IF ANY SYMPTOMS AROSE FROM THE RETAINED PIECE OF EPIDURAL CATHETER. THEIR MOST RECENT FOLLOW UP VISIT IN JUNE DID NOT REPORT ANY SYMPTOMS FROM THE RETAINED CATHETER. SAMPLE WAS NOT SAVE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITH MEDICAL PAIN MANAGEMENT/PORTEX EPIDURAL CONTINUOUS TRAYS CAUSED CATHETER TO BREAK ON A WOMEN IN LABOR RECEIVING PAIN RELIEF. ANESTHESIOLOGY ATTEMPTED TO PLACE A L4 AND L5 EPIDURAL ON ONE ATTEMPT THERE WAS A LOSS OF RESISTANCE WHEN THE CATHETER WAS THREAD. THE ANESTHESIOLOGY FELT SOME RESISTANCE SO THEY STOPPED. THE PATIENT REPORTED A TRANSIENT RIGHT SIDE PARENTHESIA SO THEY DECIDED TO PULL THE CATHETER AND REPOSITION. THE CATHETER WAS AT 12CM AT THE TOUHY NEEDLE HUB. WHEN THE ANESTHESIOLOGY PULL THE CATHETER THEY FELT A SUDDEN SNAP. THE CATHETER WAS REPORTED TO BREAK OFF INSIDE THE PATIENT. THE NEEDLE SKIN WAS INSPECTED AND THE COILED WIRE WAS STILL IN THE PATIENT, IT WAS PULLED AND REMOVED. WHEN THE CATHETER WAS INSPECTED BY PROVIDER, IT WAS FOUND BROKEN AT APPX 4CM. MORE INFORMATION REVEALED THE WOMEN HAD AN MRI AFTER INCIDENT AND NEUROSURGERY WAS CONSULTED AND TOLD PATIENT NO FURTHER INTERVENTION AND TO FOLLOW UP WITH OUTPATIENT CARE. JUNE WAS LAST VISIT PATIENT WAS SEEN AND NO ADVERSE EVENT REPORTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729176 PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS EPIDURAL CAZ 3922278 30351688081661

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention| S