MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SPINAL ANESTHESIA TRAYS

Catalog Number A1170-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Awareness during Anaesthesia (1707)

Event Type  Injury  

Event Description

A report was received that stated a pt received insufficient local anesthesia when the listed med device was used.It was necessary to place the pt under general anesthesia during the procedure.No adverse effects to pt reported.

Manufacturer Narrative

The device is currently being evaluated; the mfr will file a follow up report detailing the results of the eval once it is completed.

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4146743
• MDR Text Key: 4927077
• Report Number: 2183502-2014-00701
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: A1170-25
• Device Lot Number: 2570276
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other