MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. BIVONA TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number CM3012S

Device Problem Air Leak (1008)

Patient Problem Ventilator Dependent (2395)

Event Date 07/06/2016

Event Type  Injury  

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

The home care nurse reported that there was a leak from tracheostomy cuff.The patient is ventilator dependent at all times and humidifier almost continuously.The trach had been reprocessed at least once using a heat disinfection by boiling water.The cuff patency was tested prior to use.Trach change required to ensure appropriate cuff inflation.Velcro neck ties are adjusted on a regular basis to minimize leak around trach.Please reference mdr: 2183502-2016-01639.That is also associated with this complaint.

Manufacturer Narrative

Device returned for evaluation ((b)(4) 2016).Additional information received (08-04-2016).

Manufacturer Narrative

The reported 7.0mm custom made tracheostomy tube was returned for investigation.Visual inspection found the device to be in good condition.During functional testing, a standard syringe was used to inflate the device cuff with 16cc's of air; the cuff inflated and deflated without difficulty.The cuff was then inflated with 16cc's of water; upon deflation, all 16cc's of water was removed.The cuff was then re-inflated with water and left to rest for 24 hours; no leaks were observed.The cuff was then inflated with air and submerged in water, no bubbles (indicating a leak) were observed escaping from the device.Investigation found the device to operate as intended.Mfr# clarification: new registration number 3012307300 (b)(4) has been received, however, this initial mdr was filed under the prior registration number 2183502 (b)(4).

• Brand Name: BIVONA TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: lisa perz ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5841088
• MDR Text Key: 50963813
• Report Number: 2183502-2016-01640
• 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
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/02/2020
• Device Catalogue Number: CM3012S
• Device Lot Number: GS008144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 57