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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EPIDURAL CONTINUOUS TRAYS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EPIDURAL CONTINUOUS TRAYS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/118CZ
Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NamePORTEX EPIDURAL CONTINUOUS TRAYS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
olomoucka 306
hranice 1, mesto 753 0 1
EZ 753 01
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
olomoucka 306
hranice 1, mesto 753 0 1
EZ 753 01
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15316081
Report Number3012307300-2022-16607
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number100/391/118CZ
Device Lot Number3958253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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