MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE

Catalog Number 670180

Device Problem Fitting Problem (2183)

Patient Problem Respiratory Distress (2045)

Event Date 04/19/2016

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 user facility reported that the tracheostomy tube was in use with patient (time in use not provided).According to reporter, the staff attempted to connect a ventilator circuit to the tracheostomy tube connector but it would not fit.According to reporter, the patient required an emergency tracheostomy tube change to address the issue.No permanent adverse effects reported.

Manufacturer Narrative

One 8.0mm tts¿ adult tracheostomy tube was returned for investigation.Visual inspection of the returned device showed that the connector was deformed and did not match the specifications for outer diameter and taper.Investigation was unable to determine the root cause of the connector deformation.(b)(4).

Event Description

Further information was received from reporting facility.According to the reporter, the event occurred during the initial use of the device and no type of humidification was in use with patient.Additionally, the reported issue was observed, immediately upon patient use, during the first attempt to connect an accessory.The reported device was not cleaned or sterilized prior to patient use.

• Brand Name: BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY 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 ; 7633833052
• MDR Report Key: 5641187
• MDR Text Key: 44738972
• Report Number: 2183502-2016-00920
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K913859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/28/2019
• Device Catalogue Number: 670180
• Device Lot Number: 2805346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2014
• 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
• Patient Outcome(s): Congenital Anomaly; Required Intervention