MAUDE Adverse Event Report: TELEFLEX INCORPORATED; ANESTHESIA CONDUCTION KIT

Catalog Number AK-05503

Device Problems Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/15/2018

Event Type  malfunction  

Event Description

Patient had epidural catheter placed by anesthesiologist; it was noted to be placed at 5 cm, and at insertion level l3/4.At 0707, patient delivered baby vaginally and the catheter was removed by rn approximately an hour later with slight resistance noted.It was then noted that the black tip was not present at the end of the catheter.Rn states she did not pull or tug on the catheter.X-ray showed curvilinear density was present superimposed over the spinal canal at t11-12.It is a thin 1-2 mm density and measures 5 mm in length.Neurosurgery ordered ct, which showed external plastic catheter in the internal wire wrapped as a coil sitting on the dorsal surface of the thoracic (11th and thoracic 12 spinal cord).Neurosurgery counseled patient.The skin overlying the epidural catheter upon its insertion is healed.There would be no ability to retrieve this catheter without an open surgical intervention.It was highly encouraged to this patient that no retrieval be attempted given its minimal benefit and potential risk.It was explained to patient multiple times that the infection risk would be overall low with a retained catheter, and that this catheter poses little to no detriment in the future.Despite this conversation patient is adamant that she wishes the foreign body to be retrieved.A few weeks later the patient went to the operating room and had catheter removed from t11 thoracic epidural space.Pathology notes: received fresh labeled "t11 thoracic epidural space" 12.5 x 0.1 cm segment of gray-tan tubing.The internal portion of tubing appears to have a coiled wire.No soft tissue was present.

• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 7863794
• MDR Text Key: 119813865
• Report Number: 7863794
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AK-05503
• Device Lot Number: 23F18D0138
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8395 DA
• Patient Weight: 99