MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. PORTEX SPINAL ANESTHESIA TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number A3311-17

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2015

Event Type  malfunction  

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.

Event Description

It was reported that during use with the listed device, patient sat up in the hospital bed and catheter broke where it secured to her skin.A new epidural had to be placed.No permanent adverse health outcome resulted from this event.

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 10 bowman drive; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5358827
• MDR Text Key: 35610618
• Report Number: 2183502-2016-00056
• 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: 01/11/2016

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: Health Professional
• Device Catalogue Number: A3311-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/11/2016
• 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): Other