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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITH MEDICAL EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. SMITH MEDICAL EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number A4283-18 CONTINUOUS
Device Problem Component Missing (2306)
Patient Problem Insufficient Information (4580)
Event Date 04/26/2021
Event Type  Injury  
Event Description
Possible retained safety tip of epidural tube. When removing the tube discovered safety tip missing. Did not show up on x-ray or ct scan. Unable to locate. X-ray on (b)(6) 2021. No foreign bodies identified. Fda safety report id # (b)(4).
 
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Brand NameSMITH MEDICAL EPIDURAL CATHETER
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11885023
MDR Text Key252945294
Report NumberMW5101535
Device Sequence Number1
Product Code CAZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA4283-18 CONTINUOUS
Device Lot NumberPORTEX LOT 4098561
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2021
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/25/2021 Patient Sequence Number: 1
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