BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUN-L-XL

    MDR report key: 4798351 · Received May 26, 2015

    Report

    Report Number
    1316297-2015-00001
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    PMA / PMN Number
    954584
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ON (B)(6) 2015, THE COMPLAINT WAS REVIEWED. AT THIS POINT IN TIME THE DEVICE WAS NOT YET RETURNED; HOWEVER, THE SUPPLIER PROVIDED PICTURES AND A VIDEO OF THE CATHETER IN QUESTION FOR EPIMED'S REVIEW. ON (B)(6)2015, THE CATHETER IN QUESTION ARRIVED AT EPIMED'S FACILITY FOR PHYSICAL REVIEW. EPIMED'S QUALITY ASSURANCE DEPARTMENT EXAMINED THE CATHETER AND THE CORRESPONDING (RX) NEEDLE. THE RX NEEDLE DID NOT SHOW ANY SIGNS OF ABUSE, I.E. BEING BENT OR ETC. NEXT, THE CATHETER WAS CLOSELY EXAMINED USING 7X MAGNIFICATION. WHILE INSPECTING THE TUN-L-XL CATHETER, IT WAS CONFIRMED THAT THERE WAS APPROXIMATELY 13.6 CM OF THE CATHETER'S (FEP) TEFLON OUTER COATING UNACCOUNTED FOR. THE ANGLE AT WHICH THE CATHETER WAS SHEARED (PROXIMAL TO DISTAL), INDICATES THAT THE CORRESPONDING RX NEEDLE MOST LIKELY REMAINED INSERTED WITHIN THE PATIENT DURING CATHETER WITHDRAW; EPIMED WARNS AGAINST THIS PRACTICE WITHIN THEIR IFU PI-004. ALSO, WHILE REVIEWING THE CATHETER, A SKIVE APPROXIMATELY 0.5 CM IN LENGTH WAS OBSERVED ON THE CATHETER'S PET INNER COATING. THIS SKIVE OCCURRED APPROXIMATELY 14.5 CM FROM THE CATHETER'S DISTAL END AND EXPOSED THE INTERNAL SPRING BENEATH; HOWEVER, THE CATHETER'S SPRING REMAINED FULLY INTACT. EPIMED HAS CONFIDENCE THAT IF THE IFU PI-004 REV. 4 (SPRING GUIDE EPIDURAL CATHETER PRODUCT) WAS ADHERED TO, DAMAGE TO THE CATHETER COULD HAVE BEEN PREVENTED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, EPIMED'S QUALITY ASSURANCE DEPARTMENT WAS NOTIFIED OF AN EVENT THAT HAD RECENTLY OCCURRED INVOLVING AN EPIMED TUN-L-XL CATHETER, (CATALOG # 155-2540). THE CUSTOMER REPORTED, "WHEN REMOVING THE CATHETER, PHYSICIAN WAS FEELING RESISTANCE. AFTER REMOVING THE CATHETER, IT DID NOT HAVE THE FEP TUBE OF ABOUT 13 CM LENGTH FROM DISTAL TIP. IT MIGHT BE REMAINING IN THE PATIENT'S BODY." TO DATE, ACCORDING TO EPIMED'S KNOWLEDGE OF THE SITUATION, THE PATIENT HAS NOT UNDERGONE ANY FURTHER SURGERY TO REMOVE THE FEP COATING THAT REMAINS IN SITU WITHIN THE PATIENT. THE ACCOUNT HAS BEEN INFORMED TO NOTIFY EPIMED IF THEY REMOVE THE FEP COATING REMNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340966 TUN-L-XL RACZ CATHETER BSO EPIMED INTERNATIONAL, INC. 155-2540 11405868

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK