MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 67SN030

Device Problems Inflation Problem (1310); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer reported the event date as (b)(6) 2016 but smiths medical was made aware of the event by the customer on (b)(6) 2016.Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.(b)(4).

Event Description

It was reported that a portex® bivona® neonatal and pediatric tts¿ (tight-to-shaft) tracheostomy tube cuff was deflated and fell out after 7 days of use.The incident was observed by the patient's mother during a tracheostomy tube change.It was noted that there was still water in the balloon outside of the tracheostomy tube but not in the cuff itself.The cuff patency was tested prior to use with sterile water and did not find an apparent leak.The tracheostomy tube was washed with half-strength hydrogen peroxide and rinsed with water between uses.The tracheostomy tube was replaced with a backup tracheostomy tube when the issue was observed.No patient injury was reported.The event was considered resolved.

Manufacturer Narrative

One bivona® flextend¿ tts¿ neonatal straight neck flange tracheostomy tube was returned for investigation.The device was received inside a plastic bag and without its original packaging.Visual inspection was performed at a distance of 12" and under normal lighting; no defects were observed.During functional testing, a syringe was used to inflate the device cuff; no leaks were observed.The device was then submerged under water and the cuff was massaged, the inflation balloon was squeezed, and the inflation line was moved back and forth, no leakage was detected.After, the device cuff was inflated with water and the cuff, inflation balloon, and inflation line were manipulated; no leakage was observed.Investigation was unable to confirm the reported device issue and found the device operated as intended.

• Brand Name: PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) 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 ; 7633833074
• MDR Report Key: 6210910
• MDR Text Key: 63476429
• Report Number: 3012307300-2016-00664
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

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: Patient Family Member or Friend
• Device Expiration Date: 06/10/2021
• Device Catalogue Number: 67SN030
• Device Lot Number: 3219766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2016
• 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 Weight: 6