MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CUSTOM BIVONA® TRACHEOSTOMY TUBE

Catalog Number FA14BN70NSC217S

Device Problem Air Leak (1008)

Patient Problems Extubate (2402); Decreased Respiratory Rate (2485)

Event Date 01/26/2016

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 product provider reported a product issue on behalf of the patient; the provider reported that the patient's tracheostomy tube spontaneously began leaking at the cuff (after an undisclosed amount of time in use).The patient's father added oxygen to the cuff for approximately 10 minutes, but the cuff would not remain pressurized.The patient's father placed the patient on an ambu bag for 30 minutes, and then performed an emergent tracheostomy tube change with the aid of a neighbor.The reporter indicated that it was not the initial use of the tracheostomy tube, and that it had been reprocessed once before.The reporter stated that no permanent adverse effects occurred during the event.The reporter suspects the customer was using the tracheostomy tube in a way that was inconsistent with the ifu, but did not clarify how.

Manufacturer Narrative

The reported custom 7.0 a/c flextend tracheostomy was returned for investigation.Visual inspection was at a distance of 12" to 24" and normal conditions of illumination and no obvious defects were found.An inflation test was performed where the cuff was inflated with 16 cc of air using a syringe and the cuff deflated slowly, indicating a presence of a small leak.The cuff was inflated again with 16 cc of air and the entire device was submerged under water and leakage was detected on the aire cuff.The root cause could not definitively be identified but the complaint was confirmed as a cuff leak.

• Brand Name: CUSTOM BIVONA® 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 road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5473706
• MDR Text Key: 39451781
• Report Number: 2183502-2016-00368
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 11/04/2020
• Device Catalogue Number: FA14BN70NSC217S
• Device Lot Number: GS004207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention