MAUDE Adverse Event Report: CAREFUSION ULTRA-SLIP STYLET; STYLET, TRACHEAL TUBE

Model Number S1000NEU

Device Problem Difficult to Insert (1316)

Patient Problem Neck Stiffness (2434)

Event Date 11/28/2013

Event Type  No Answer Provided  

Event Description

The pt has a difficult airway.Small mouth, stiff neck, which why intubation is planned with videolaryngoscope.They first try with normal blade, then small curved blade without getting any view.With a long curved blade, they get a nice view, but intubation only succeeds after 5 trails, because the new stilettes, "ultra-slip endotracheal tube stylet", are too soft, smooth and have a tendency to back out the tube.After having collected a stable stilette: "intubating stylet, unomedical", the pt is intubated without any problem.Sao2 was 100% during the entire procedure, it was difficult to mask ventilate.Result: because the pt was increasingly hard to ventilate with a mask, and as unimedical intubation stylets, according to sfr for anaesthesiology cannot be used as standard, it had to be collected outside anesthesia room, the incident must be registered as a "near miss".

Manufacturer Narrative

(b)(4).Carefusion acquired ge vital signs on (b)(6) 2013.A retrospective review of all complaints post acquisition was performed.This complaint was identified as being mdr reportable by cfn standards and is being submitted to the fda.Upon carefusion's investigation, a follow up medwatch will be submitted.

• Brand Name: ULTRA-SLIP STYLET
• Type of Device: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): CAREFUSION; 11039 e. lasing circle; englewood CO 80112 590
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3836268
• MDR Text Key: 4390311
• Report Number: 1718887-2014-00002
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K914965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S1000NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other