MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA® MID-RANGE ADULT AIRE-CUF® ADJUSTABLE NECK FLANGE HYPERFLEX TRACHEOSTOMY; TRACHEOSTOMTY TUBE

Catalog Number 75HA80

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

User facility reported that the device was placed in use with patient and cuff leak was noted which required the staff to apply high cuff inflation pressure.The patient was reported to have complex anatomy and the correct position of the tube was verified by staff.According to reporter, after 4 days' use with patient the user facility removed the device and replaced with another.Upon removal, user facility determined that the cuff had been leaking.No adverse effects to patient reported.

Manufacturer Narrative

One sample returned for evaluation.Visual inspection did not reveal any obvious defects.Cuff was inflated with 30 cc of air using a syringe to check the inflation behavior.Cuff inflated normally and held air without any obvious sign of deflation or leakage.Deflation was also found to perform as intended.System leak test was carried out by inflating the cuff with 30 cc of air and submerging the entire unit under water.No leaks were detected during this leak test.No leaks or defects detected during investigation of returned unit.The device was found to be working as expected.

• Brand Name: BIVONA® MID-RANGE ADULT AIRE-CUF® ADJUSTABLE NECK FLANGE HYPERFLEX TRACHEOSTOMY
• Type of Device: TRACHEOSTOMTY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5100633
• MDR Text Key: 26635070
• Report Number: 2183502-2015-00698
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/24/2015

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: 75HA80
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1