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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® CSECURE® SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACKS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL, ASD, INC. PORTEX® CSECURE® SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACKS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 928/118/0008
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Headache (1880)
Event Date 04/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a portex® csecure® spinal and epidural needle assembly - minipack has caused a headache for an obstetric patient prolonging the patient's stay. The patient suffered an intense headache. No medical intervention was needed.
 
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Brand NamePORTEX® CSECURE® SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACKS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL, ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA, KEENE
10 bowman drive
keene NH 03431
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7643432
MDR Text Key112515647
Report Number3012307300-2018-02519
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number928/118/0008
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2018 Patient Sequence Number: 1
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