BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW EPIDURAL CATHETERIZATION KIT

    MDR report key: 21383869 · Received February 14, 2025

    Report

    Report Number
    9680794-2025-00115
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    January 11, 2025
    Report Date
    January 22, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    BSO
    UDI-DI
    50801902013694
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER REPORTED THE EPIDURAL CATHETER BROKE DURING REMOVAL. THE CUSTOMER RETURNED ONE CATHETER ADAPTER AND TWO EPIDURAL CATHETER PIECES. THE COMPONENTS WERE RECEIVED CONNECTED TOGETHER. THE RETURNED COMPONENTS WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXANIMATION OF THE RETURNED CATHETER ADAPTER REVEALED THE ADAPTER APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. VISUAL EXAMINATION OF THE RETURNED CATHETER PIECES REVEALED ON THE LIKELY MOST PROXIMAL PIECE, THE EXTRUSION AND COIL WIRE ARE EXTREMELY STRETCHED AT THE LIKELY DISTAL END. THE EXTRUSION AND COIL WIRE ON THE LIKELY MOST DISTAL PIECE ARE ALSO STRETCHED AT THE POINT OF SEPARATION AT THE LIKELY PROXIMAL END. ALSO, BOTH THE PROXIMAL AND DISTAL ENDS OF THE RETURNED CATHETER PIECES APPEAR TO BE INTACT. THE CATHETER APPEARS TO HAVE BEEN USED AS BIOLOGICAL MATERIAL CAN BE SEEN BETWEEN THE INNER COILS. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE CUSTOMER ALSO PROVIDED PHOTOS THAT APPEAR TO SHOW AN EPIDURAL KIT LIDSTOCK. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE CATHETER USING A RULER. THE PROXIMAL END CATHETER EXTRUSION PIECE MEASURES APPROXIMATELY 88.1CM. THE DISTAL END CATHETER PIECE MEASURES APPROXIMATELY 8.2CM. BOTH CATHETER PIECES COMBINE TO MEASURE APPROXIMATELY 96.3CM. NONE OF THE CATHETER APPEARS TO BE MISSING. HOWEVER, WITH THE COILS AND EXTRUSION BEING STRETCHED, THIS IS WHY THE CATHETER IS OUTSIDE OF THE SPECIFICATION OF 88.5-91.5 CM PER GRAPHIC. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER WITH NO RELEVANT FINDINGS. THE IFU FOR THIS KIT, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU WARNS THE USER, "NEVER TUG OR QUICKLY PULL-ON CATHETER DURING REMOVAL FROM PATIENT TO REDUCE RISK OF CATHETER BREAKAGE. DO NOT APPLY ADDITIONAL TENSION ON THE CATHETER IF CATHETER BEGINS TO STRETCH EXCESSIVELY. REPOSITION PATIENT TO OPEN THE VERTEBRAL INTERSPACES AND REATTEMPT REMOVAL IF RESISTANCE IS ENCOUNTERED OR IF CATHETER STRETCHES EXCESSIVELY DURING REMOVAL. THE REPORTED COMPLAINT OF EPIDURAL CATHETER BREAKING DURING REMOVAL WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE CUSTOMER RETURNED TWO CATHETER PIECES THAT WERE SEPARATED AT THE EXTRUSION. NONE OF THE CATHETER APPEARED TO BE MISSING. AT THE POINT OF SEPARATION, THE EXTRUSION AND COIL WIRE WERE EXTREMELY STRETCHED ON THE LIKELY PROXIMAL PIECE AND WAS ALSO STRETCHED ON THE LIKELY DISTAL PIECE. THE IFU FOR THIS PRODUCT WARNS THE USER NOT TO APPLY ADDITIONAL TENSION IF THE CATHETER BEGINS TO STRETCH AS THERE IS A RISK FOR SEPARATION. THEREFORE, BASED UPON THE CONDITION OF THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "ON (B)(6) 2024, WE HAD A LABORING PATIENT WHO HAD AN EPIDURAL CATHETER PLACED FOR PAIN CONTROL BY ANESTHESIA AT 1650. ONCE THE PATIENT DELIVERED, A REGISTERED NURSE (RN) ATTEMPTED TO REMOVE THE EPIDURAL CATHETER WITH SLIGHT RESISTANCE NOTED WITH GENTLE TRACTION. THE RN DIRECTED PATIENT TO CURL FORWARD. THE EPIDURAL CATHETER NOTED TO REMOVE WITH GENTLE, STEADY TRACTION. DURING THIS, THE PATIENT WAS NOTED TO SLIGHTLY ADJUST UPRIGHT DURING THIS PROCESS. THE EPIDURAL CATHETER CAME OUT AND APPEARED SHEARED WITH NO BLACK TIP COLOR MARKING OBSERVED. THE PATIENT HAD THE EPIDURAL CATHETER REMOVED AT ANOTHER ACUTE CARE FACILITY ON (B)(6) 2024 AFTER DISCHARGING FROM (B)(6). WE HAD THIS EVENT INVESTIGATED AND THE CATHETER WAS REMOVED ACCORDING TO POLICY. THE PATIENT IS REPORTED TO BE DOING WELL."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "ON (B)(6)2024, WE HAD A LABORING PATIENT WHO HAD AN EPIDURAL CATHETER PLACED FOR PAIN CONTROL BY ANESTHESIA AT 1650. ONCE THE PATIENT DELIVERED, A REGISTERED NURSE (RN) ATTEMPTED TO REMOVE THE EPIDURAL CATHETER WITH SLIGHT RESISTANCE NOTED WITH GENTLE TRACTION. THE RN DIRECTED PATIENT TO CURL FORWARD. THE EPIDURAL CATHETER NOTED TO REMOVE WITH GENTLE, STEADY TRACTION. DURING THIS, THE PATIENT WAS NOTED TO SLIGHTLY ADJUST UPRIGHT DURING THIS PROCESS. THE EPIDURAL CATHETER CAME OUT AND APPEARED SHEARED WITH NO BLACK TIP COLOR MARKING OBSERVED. THE PATIENT HAD THE EPIDURAL CATHETER REMOVED AT ANOTHER ACUTE CARE FACILITY ON (B)(6)2024 AFTER DISCHARGING FROM MJE. WE HAD THIS EVENT INVESTIGATED AND THE CATHETER WAS REMOVED ACCORDING TO POLICY. THE PATIENT IS REPORTED TO BE DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623108 ARROW EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL LLC 33F24H0029 50801902013694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.| NOT REPORTED.