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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL KITS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX® SPINAL KITS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 4966-25
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint. The anesthetic is a supplied item and the complaint notification was forwarded to the supplier. Records analysis was performed by the supplier for bupivacaine-marcaine lot #'s 622453a and confirmed that the reported lot continues to meet all specifications. Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.
 
Event Description
It was reported that a marcaine medication in portex® spinal kits was ineffective. No patient injury reported.
 
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Brand NamePORTEX® SPINAL KITS
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
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key7554312
MDR Text Key109816062
Report Number3012307300-2018-10218
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 05/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4966-25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/28/2016
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

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