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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL EPIDURAL CUSTOM KIT; ANESTHESIA CONDUCTION KIT Back to Search Results
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.
 
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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 Key5107902
MDR Text Key26883162
Report Number2183502-2015-00709
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeEI
Number of Events Reported1
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 Date03/31/2020
Device Catalogue Number922/018/0403
Device Lot Number2931382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/28/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age33 YR
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