MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA FLEXTEND¿ TTS¿ PEDIATRIC CUSTOM TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter noted an invalid lot number of 2887399.The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.

Event Description

It was reported that the cuff of a portex® bivona flextend¿ tts¿ pediatric custom tracheostomy tube still inflated after the pilot balloon completely deflated.The fault was noticed within a week of the tracheostomy tube being placed.No patient injury was reported.See mfr: 3012307300-2017-01056.

Manufacturer Narrative

Upon receipt of the returned product sample, it was visually examined.One used customized tracheostomy tube was received.No visual anomalies were noted.Functional testing was performed using a syringe and 5cc's of air to inflate the cuff.The cuff inflated and deflated as expected.This process was repeated 10 times in total with consistent successful results.Leak testing was also performed and found no leaks.The reported issue could not be confirmed.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX® BIVONA FLEXTEND¿ TTS¿ PEDIATRIC CUSTOM 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.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6581761
• MDR Text Key: 75684844
• Report Number: 3012307300-2017-01126
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SERVO-L VENTILATOR; SYRINGE