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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX COMBINED SPINAL EPIDURAL CSECURE TRAYS; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD, INC PORTEX COMBINED SPINAL EPIDURAL CSECURE TRAYS; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number 100/491/916
Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2019
Event Type  malfunction  
Event Description
It was reported that two days into post operative pain management, the tip of the epidural catherter sheared.The tip was not found in the patient's body following ct and mri scans.No patient injury was reported in relation to this event.
 
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Brand Name
PORTEX COMBINED SPINAL EPIDURAL CSECURE TRAYS
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL, ASD INC.
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key8778797
MDR Text Key150714453
Report Number3012307300-2019-03774
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Type of Report Initial
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/08/2023
Device Catalogue Number100/491/916
Device Lot Number3592299
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2018
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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