MAUDE Adverse Event Report: B.BRAUN 20 GAUGE CLOSED TIP POLYMIDE NYLON CATHETER; EPIDURAL CATHETER

Model Number 551370

Device Problems Fracture (1260); Device, or device fragments remain in patient (1527); Defective Component (2292)

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Date 12/24/2014

Event Type  Injury  

Event Description

(b)(6) female entered operating room for rthr (right total hip replacement) revision.Spinal epidural was attempted at level l4-5, then at level l5-s1; appropriate space could not be found.For a third attempt, which was successful, a new epidural needle was utilized at the l3-4 interspace.After obtaining loss of resistance at this level, a 27g whitacre needle was inserted and csf (cerebral spinal fluid) was obtained.The anesthesiologist then gave the intrathecal dose of local anesthetic, the spinal needle was removed and an epidural catheter was threaded through the epidural needle.The anesthesiologist was able to thread the catheter 20cm with no resistance or problem.The epidural needle was then removed without any problem.Subsequently, the anesthesiologist attempted to pull back the catheter to the desired length; the plan was to pull it back to 15cm at the skin, as loss of resistance was obtained at 9cm.She was able to pull back approximately 4cm, then met resistance in the catheter.She then found that the catheter had broken.Upon removal, it was noted that approximately 10 cm of epidural catheter had remained in the patient, based on surface anatomy, in the epidural space or subcutaneous tissue of l3-4.Throughout the process, the patient was awake, slightly sedated and comfortable.Her vital signs were stable and she reported no pain or discomfort.Surgery was uneventful.The anesthesiologist saw the patient post-operatively; the patient had no neurologic deficits, nor signs of infection.The anesthesiologist held three lengthy discussions with the patient and family, first post-operatively, then on pod (post operative day) #1, and pod#2 regarding the occurrence and retained catheter.Examination revealed no visible fragment nor tract in the patient's back.In accordance with standard of care, the patient was advised to contact the anesthesiologist and/or primary physician immediately for evaluation in the event of any signs/symptoms of infection or neurologic deficit.The patient and family fully understood, and all questions were answered.The patient was discharged to a rehabilitation facility on (b)(6) 2014.The plan, if no issue arises prior, was for her post-operative visit to the surgeon at 4-6 weeks post-operatively.The patient did not report any issues and saw the surgeon for her post-operative visit on (b)(6) 2015, at which time she was doing very well with her recovery.There were no issues with the catheter fragment.

• Brand Name: 20 GAUGE CLOSED TIP POLYMIDE NYLON CATHETER
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B.BRAUN; bethelehem PA 18011
• MDR Report Key: 4738913
• MDR Text Key: 5703134
• Report Number: 4738913
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 551370
• Other Device ID Number: ITEM 333540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 96