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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. PORTEX® CONTINUOUS EPIDURAL TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number A4219-17
Device Problems Material Separation (1562); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Date 09/15/2016
Event Type  Injury  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation. (b)(4).
 
Event Description
It was reported that the infusion catheter of an epidural tray separated from itself and remained in the patient. Hospital contact has no information on the status of that patient. Additional information has been requested and not received. No adverse events reported at ths time.
 
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Brand NamePORTEX® CONTINUOUS EPIDURAL TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6064867
MDR Text Key58699817
Report Number3012307300-2016-00227
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 10/07/2001
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA4219-17
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 Received10/07/2016
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 Initial

Patient Treatment Data
Date Received: 10/28/2016 Patient Sequence Number: 1
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