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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® EPIDURAL MINIPACK ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX® EPIDURAL MINIPACK ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/116CZ
Device Problems Material Fragmentation (1261); Difficult to Insert (1316); Use of Device Problem (1670)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/23/2018
Event Type  Injury  
Manufacturer Narrative
Additional information was received indicating that the break of the epidural catheter occurred as the catheter was withdrawn from the needle while in the patient. Reporter states that this is caused by user error, not the failure of the smiths medical product.
 
Manufacturer Narrative
Report source: (b)(6). This device is same and/or similar to a device approved for distribution in the us.
 
Event Description
It was reported that during epidural insertion, the catheter of a portex® epidural minipack was difficult to thread through. When withdrawn, the tip was missing. Approximately 5cm of the catheter sheared off in the epidural space. An anesthetist was consulted and a plan was made for the patient. No permanent injury was reported.
 
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Brand NamePORTEX® EPIDURAL MINIPACK
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.
olomoucká 306
hranice 1 - mesto
hranice, 753 0 1
EZ 753 01
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7263254
MDR Text Key108411736
Report Number3012307300-2018-00240
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,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number100/391/116CZ
Device Lot Number3461463
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/12/2018 Patient Sequence Number: 1
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