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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
Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)
Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Anxiety (2328); Depression (2361); Device Embedded In Tissue or Plaque (3165)
Event Date 01/27/2015
Event Type  Injury  
Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that during the patient's third labor, a portex® epidural minipack failed, and the patient consequently suffered from neurological problems and pain as well as depression and anxiety. It was also noted that during the introduction of the device, blood appeared while pulling out the catheter. The catheter's tip was torn, and 7cm of it "were left inside". Additional information regarding the event and patient's condition was requested, however the reporter stated no further information is available.
 
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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
jennifer meng
6000 nathan lane north
minneapolis, MN 55442
7633833078
MDR Report Key6745057
MDR Text Key81086265
Report Number3012307300-2017-01601
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 07/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/26/2017 Patient Sequence Number: 1
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