MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA® 3.5MM PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Device Problem Air Leak (1008)

Patient Problems Low Oxygen Saturation (2477); Bronchospasm (2598)

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.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 a bivona® 3.5mm pediatric tracheostomy tube cuff experienced a leak while on a ventilator during use on a patient in the hospital.Patient experienced desaturation and bronchospasms.Albuterol was administered.The patient responded and stabilized quickly, and the tracheostomy tube was changed.It was noted that there were no issues during the tracheostomy tube change, and the patient did well.Otolaryngologist fellow noted the tube defect could not be determined to be the cause of the bronchospasm, since the patient had history of bronchospasms and need for albuterol.No permanent injury was reported.See mfr: 3012307300-2017-00966.

• Brand Name: BIVONA® 3.5MM PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 6547786
• MDR Text Key: 74551596
• Report Number: 3012307300-2017-01046
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/05/2017
• 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