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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number A2832-25
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that the bupivacaine contained in the portex® spinal anesthesia tray was ineffective.No patient death or serious injury was reported in connection with this incident.
 
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Brand Name
PORTEX® SPINAL ANESTHESIA TRAYS
Type of Device
ANESTHESIA 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 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7508210
MDR Text Key108048411
Report Number3012307300-2018-10241
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00351688061761
UDI-Public00351688061761
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 Nurse
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberA2832-25
Device Lot Number3307758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BUPIVACAINE
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