MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. PORTEX COMBINED SPINAL EPIDURAL ANESTHESIA TRAYS; CAZ-ANESTHESIA CONDUCTION

Catalog Number A2744-17/27

Device Problem Sticking (1597)

Patient Problem Headache, Lumbar Puncture (2186)

Event Type  Injury  

Event Description

User facility reported that the device was placed in use with patient and the loss of resistance syringe component was not providing proper feedback during epidural placement.According to reporter, patient received dura puncture.Patient received an epidural blood patch and was given various analgesic medications for approximately one week.No permanent adverse effects to patient reported.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: PORTEX COMBINED SPINAL EPIDURAL ANESTHESIA TRAYS
• Type of Device: CAZ-ANESTHESIA CONDUCTION
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL MD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3833402
• MDR Text Key: 4392836
• Report Number: 2183502-2014-00315
• 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: Physician
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A2744-17/27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2014
• Event Location: Hospital
• Date Manufacturer Received: 04/16/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention