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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD; INC. PORTEX® CONTINUOUS EPIDURAL ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/019CZ
Device Problems Positioning Problem (3009); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2019
Event Type  malfunction  
Event Description
Information was received indicating that during placement of a smiths medical portex® continuous epidural the loss of resistance was not felt leading to the needle being pushed too far. Analgesia was reported to be satisfactory and was removed following the case as planned. There were no reported patient complications.
 
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Brand NamePORTEX® CONTINUOUS EPIDURAL
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL CZECH REPUBLIC A. S.
olomouck 306,
hranice 1
mesto, 753 0 1
EZ 753 01
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key9549549
MDR Text Key176078955
Report Number3012307300-2020-00091
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 01/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number100/391/019CZ
Device Lot Number3833564
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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