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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD,INC. PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 100/391/128CZ
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/21/2020
Event Type  malfunction  
Event Description
Information received a smiths medical pain management portex epidural continuous trays was noticed by the anesthetist a leak.No injury or clinical consequence was observed.When inserting the epidural the anesthetist found no difficulties, but he could not inject the treatment.He then changed the yellow tip but nothing flowed out the catheter.After removing, shortening and re-introducing the catheter, there was still the same issue.The anesthetist changed the catheter and there was no issue.No further information was provided.
 
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Brand Name
PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD,INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key10434180
MDR Text Key203800196
Report Number3012307300-2020-06858
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number100/391/128CZ
Device Lot Number3954778
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Date Manufacturer Received07/21/2020
Was Device Evaluated by Manufacturer? No
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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