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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.
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Manufacturer (Section D)
2400 bernville road
reading PA 19605
MDR Report Key7863794
MDR Text Key119813865
Report Number7863794
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received09/11/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAK-05503
Device Lot Number23F18D0138
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/2018
Event Location Hospital
Date Report to Manufacturer09/11/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/11/2018 Patient Sequence Number: 1