MAUDE Adverse Event Report: CAREFUSION STYLET NEONATAL ENDOTRACHEAL TUBE GUIDE; STYLET, TRACHEAL TUBE

Model Number S5000N

Device Problem Detachment Of Device Component (1104)

Patient Problem Extubate (2402)

Event Date 04/18/2014

Event Type  Injury  

Event Description

One ultraslip stylet blue cover came off the metal part while trying to intubate an infantissue occurred on (b)(6) 2014 according to customer.Sales rep (b)(4), informed on (b)(4) 2014 and customer was give the vital signs customer support phone number.Additional information received from (b)(6) on (b)(4) 2014: no harm to the patient.The blue cover was coming off  about 3 cm from the tip.Et tube was pulled when the stylet came out without the tip.Pt reintubated with new et tube and stylet.Additional information received on (b)(4) 2014 from customer ((b)(6)): the issue was noticed after the stylet was removed.The et tube was removed and the rest of the blue covering of the stylet was still in the et tube and appeared to be complete.Patient was reintubated with new set-up.No other medical intervention was done.

Manufacturer Narrative

(b)(4).Device evaluation anticipated but has not yet begun.Upon carefusion's investigation, a follow up medwatch will be submitted.

Manufacturer Narrative

(b)(4).Investigation summary: one sample was returned by the customer, but it was lost in the shipping/receiving process.Therefore, the reported condition could not be confirmed.A lot number was not provided for evaluation.As such, device history records could not be reviewed at this time.A two year complaint trend was performed and it was observed that no similar complaints have been reported where the sheath came off of the stylet while attempting to intubate.As a part of the manufacturing process, stylets receive a 100% visual inspection by operators to ensure that the sheathes are fully welded.Additional samples are pulled and inspected by qc personnel during the final inspection and release process.With each work order that is manufactured, supervisors are responsible for verifying the training of personnel involved in the job.All employees involved in the manufacturing of finished stylets have been trained on the appropriate operating and inspection procedures.There were no discrepancies noted from the receiving or manufacturing process that could impact product functionality or be linked to the condition reported.The stylet sheath for (b)(4), is a purchased component.There have been no changes to the material specification since july 2006.Receiving inspection records for the component were reviewed from january 2012 to present, and all received materials met the relevant acceptance criteria.At this time, a root cause cannot be determined with no sample and no lot number available for evaluation.This issue will be re-evaluated if more information becomes available in the future.

• Brand Name: STYLET NEONATAL ENDOTRACHEAL TUBE GUIDE
• Type of Device: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION/VITAL SIGNS; 11039 lansing cir; englewood CO 80112
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3840861
• MDR Text Key: 16797213
• Report Number: 1718887 -2014-00003
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: S5000N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention