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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX - SMITHS MEDICAL ASD, INC. EPIDURAL SINGLE SHOT EPIDURAL ANESTHESIA CONDUCTION KIT

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PORTEX - SMITHS MEDICAL ASD, INC. EPIDURAL SINGLE SHOT EPIDURAL ANESTHESIA CONDUCTION KIT Back to Search Results
Lot Number 3802013
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2019
Event Type  malfunction  
Event Description
Portex (b)(4) epidural single shot trays had a drape that is listed as fenestrated but there was no hole in the drape. This has involved at least 5 cases in this lot number. Fda safety report id# (b)(4).
 
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Brand NameEPIDURAL SINGLE SHOT EPIDURAL
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
PORTEX - SMITHS MEDICAL ASD, INC.
minneapolis MN
MDR Report Key8703723
MDR Text Key148295355
Report NumberMW5087389
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/12/2019
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received06/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2021
Device Lot Number3802013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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