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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EPIDURAL MINI PACK SYSTEM ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. EPIDURAL MINI PACK SYSTEM ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/116CZ1
Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 07/09/2018
Event Type  Injury  
Event Description
It was reported that 7 cm of the epidural catheter broke off inside the patient who was undergoing a caudal epidural. The patient had to undergo a further procedure to remove the retained catheter. No further complications were reported.
 
Manufacturer Narrative
The investigation of the complaint was limited because no sample was returned. Due to the fact that reported issue occurred during procedure it is the most probable that the catheter was cut off by tuohy needle when catheter was pulled back which is in conflict with instruction for use l6308 rev. 100, warnings, point 1: "never pull back the catheter through the epidural tuohy needle as this can result in the catheter being cut and left in the epidural space. If catheter insertion difficulties are encountered, the epidural tuohy needle and catheter should be removed carefully together as a single unit, and the procedure repeated".
 
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Brand NameEPIDURAL MINI PACK SYSTEM
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL CZECH REPUBLIC A. S.
olomouck 306
hranice 1 - mesto
hranice, 75301
EZ 75301
Manufacturer Contact
dave halverson
1265 grey fox road
st. paul, MN 55112
7633833310
MDR Report Key7789480
MDR Text Key117310020
Report Number3012307300-2018-03297
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/15/2020
Device Catalogue Number100/391/116CZ1
Device Lot Number2994496
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/16/2018 Patient Sequence Number: 1
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