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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE ANESTHESIA CONDUCTION KIT PRODUCT CODE: CAZ

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SMITHS MEDICAL ASD, INC. PORTEX SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE ANESTHESIA CONDUCTION KIT PRODUCT CODE: CAZ Back to Search Results
Catalog Number 15858-1
Device Problems Break (1069); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/07/2019
Event Type  Injury  
Event Description
Information was received that a smiths medical portex spinal 24g european pencil point with introducer needle broke off during insertion. "after an x-ray and ct scan a porting of the needle was found in the patient back. And it will be remove at a later date. " no adverse patient effects were reported.
 
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Brand NamePORTEX SPINAL 24G EUROPEAN PENCIL POINT WITH INTRODUCER NEEDLE
Type of DeviceANESTHESIA CONDUCTION KIT PRODUCT CODE: CAZ
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 Key8681464
MDR Text Key147436259
Report Number3012307300-2019-03434
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 health professional,other,use
Reporter Occupation
Type of Report Initial
Report Date 06/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number15858-1
Device Lot Number3744858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/09/2019 Patient Sequence Number: 1
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