MAUDE Adverse Event Report: SMITHS MEDICAL EPIDURAL CUSTOM KIT; ANESTHESIA CONDUCTION KIT

Catalog Number 922/018/0403

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2015

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that upon removal of the epidural catheter after 8 hours in use, there was blood on aspiration.Resistance was felt upon pulling back on catheter and it snapped.Mri and ct scan done to check lumbar space which did not reveal that any catheter fragments remained in the patient.No permanent injury resulted from this event.

Manufacturer Narrative

The manufacturing facility performed a device history review of the lot number reported (2931382): the review showed no deviations or abnormalities related to the reported issue.One used catheter was returned to smiths medical and routed to the manufacturing facility.The returned device was examined: this examination showed the catheter tip was broken off; this break in the material was determined consistent with the device having been exposed to a sharp edge.No signs of pull stress were identified on the returned sample.The manufacturing facility performed an investigation of the manufacturing processes for production of the catheter component; this investigation showed no practices that could induce the conditions observed on the returned catheter.The manufacturing process includes a 100% inspection of the catheter component and had any damage been present at that time the catheter would have been rejected.The root cause could not be definitely established but could not be attributed to manufacturing.

• Brand Name: EPIDURAL CUSTOM KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL; 10 bowman drive; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5107902
• MDR Text Key: 26883162
• Report Number: 2183502-2015-00709
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 922/018/0403
• Device Lot Number: 2931382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33 YR