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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS PORTEX® SPINAL ANESTHESIA TRAYS, PRODUCT CODE CAZ

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SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS PORTEX® SPINAL ANESTHESIA TRAYS, PRODUCT CODE CAZ Back to Search Results
Catalog Number NLD-15248C-22/25
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
There are two potential lot numbers involved with this complaint and they are as follows: 3177846 and 3120762.
 
Event Description
It was reported that the hospital had multiple incidents of drug failures with bupvivaine 0. 75% in dectrose 8. 25%, @ ml procedure drug vial that is in the spinal tray. No adverse health outcomes were reported.
 
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Brand NamePORTEX® SPINAL ANESTHESIA TRAYS
Type of DevicePORTEX® SPINAL ANESTHESIA TRAYS, PRODUCT CODE CAZ
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
halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7508290
MDR Text Key108156168
Report Number3012307300-2018-10169
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
Reporter Occupation
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNLD-15248C-22/25
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/28/2016
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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