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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number EPX1360/118JP
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that medical fluid leaked from the epifuse connector.No serious injury was reported in connection with this incident.
 
Manufacturer Narrative
One epifuse connector of portex® epidural was return for analysis.Upon visual exam a crack was noted in the hinge portion of the epifuse connector; confirming complaint.Based on the evidence the root cause was due to the supplier.
 
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Brand Name
PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS
Type of Device
ANESTHESIA 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 OH 03431 0724
Manufacturer Contact
dave halverson
1265 grey fox road
st. paul, MN 55112
7633833310
MDR Report Key7771940
MDR Text Key116720461
Report Number3012307300-2018-03173
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberEPX1360/118JP
Device Lot Number180418
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received08/15/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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