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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/382/116CZ
Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Patient Problems Pain (1994); Numbness (2415); Foreign Body In Patient (2687)
Event Date 10/23/2019
Event Type  Injury  
Manufacturer Narrative
Report source: report source: (b)(6).
 
Event Description
Information was received that a smiths medical portex epidural catheter was inserted by hospital staff a patient's surgery. The reporter stated the device was placed at patient's l5 and ruptured while in use. It was reported the patient had pain with numbness in their legs and their surgery was delayed. Upon initial imaging of the catheter, the 5cm fragment could not be located and remained in the patient's body. The reporter then stated at a later date that "the catheter was located on a second resonance and is currently at l1". Subsequently, the patient was operated on two days after the event and discharged the following day. Additionally, the patient's pain and numbness was noted to have decreased. No additional adverse patient effects were reported.
 
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Brand NamePORTEX EPIDURAL CATHETER
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
olomouck 306,
hranice 1 - mesto
hranice,
EZ
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key9323943
MDR Text Key166636262
Report Number3012307300-2019-06435
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2020
Device Catalogue Number100/382/116CZ
Device Lot Number3086868
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2015
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: 11/14/2019 Patient Sequence Number: 1
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