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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SINGLE SHOT EPIDURAL TRAYS

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SMITHS MEDICAL ASD, INC. PORTEX SINGLE SHOT EPIDURAL TRAYS Back to Search Results
Catalog Number 4947-18
Device Problem Difficult to Insert (1316)
Patient Problem Pain (1994)
Event Type  malfunction  
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Brand NamePORTEX SINGLE SHOT EPIDURAL TRAYS
Type of DeviceEPIDURAL
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15327048
Report Number3012307300-2022-16972
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2022
Device Catalogue Number4947-18
Device Lot Number4167658
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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