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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 49661C-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Awareness during Anaesthesia (1707); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that a portex® spinal anesthesia tray was used for a cesarian section. It was observed that the user had a "positive swirl" two times and the patient's anesthesia level was deemed appropriate for the procedure. It was noted that 25mcg of fentanyl was added to the included bupivacaine dose. When the user made an incision, the patient experienced intense pain and was unable to lay still for the procedure. The patient was intubated to complete the procedure. No permanent injury was reported.
 
Manufacturer Narrative
Six sealed trays of marcaine-bupivacaine ampules (lot number 3318794) were returned for investigation. Visual inspection of six of the ampules from the returned trays found no visible non-conformities. The drug liquid was found to be clear (colorless) with no particulates visible inside the vials. Review of the device history record and incoming records found no discrepancies or anomalies relevant to the complaint. Assay testing, which was performed by the supplier prior to release of the lot found that the reported lot was within specification. Review of the sterilization certificate for the reported lot number revealed that the product was processed according to validated specification requirements and parameters. Smiths medical monitors supplied drug components stability post ethylene oxide sterilization throughout their expiry. Records find that the supplied drug components continue to meet potency specification. Investigation was unable to confirm the reported issue and found that the devices operated as intended.
 
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Brand NamePORTEX® SPINAL ANESTHESIA TRAYS
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
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6439268
MDR Text Key71033354
Report Number3012307300-2017-00762
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier30351688047117
UDI-Public30351688047117
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/03/2018
Device Catalogue Number49661C-25
Device Lot Number3318794
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2016
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: 03/28/2017 Patient Sequence Number: 1
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