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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL, ASD, INC. PORTEX® SPINAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number A4037-25
Device Problem Degraded (1153)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 11/29/2017
Event Type  malfunction  
Manufacturer Narrative
No sample was received for investigation. A review of the device history record found no discrepancies or anomalies relevant to the complaint. Assay testing was performed by the supplier prior to the release of bupivacaine lot number 77-398-ev. Review of the sterilization certificate for the tray lot number 3516651 revealed that the product was processed according to validated specification requirements and parameters. The anesthetics are supplied items and a notification was forwarded to the supplier. Based on available information and evidences, no product quality problem could be confirmed. Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.
 
Manufacturer Narrative
See mfr: 3012307300-2017-2536.
 
Event Description
It was reported that there was questionable potency (of marcaine) in face of a single pass easy placement of a spinal needle from a portex® spinal anesthesia tray. The patient had no motor block and required more intra-operative medications. This is consistent with bad marcaine. Marcaine is a local anesthetic. No adverse events were reported.
 
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Brand NamePORTEX® SPINAL ANESTHESIA TRAY
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
7633833310
MDR Report Key7106100
MDR Text Key196332323
Report Number3012307300-2017-02535
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2019
Device Catalogue NumberA4037-25
Device Lot Number3516651
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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