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

Catalog Number 67P055

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

Pma510(k): additional 510(k) number: k914088.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.

Event Description

It was reported that the cuff of a bivona® pediatric tts¿ tracheostomy tube experienced a leak after three days of use.The leak was discovered during use.Cuff integrity was tested prior to use, and air was used to inflate the cuff.A standard tracheostomy tube change was performed after the incident occurred.No permanent injury was reported.

Manufacturer Narrative

Device evaluation : one bivona sample was received in used condition without its original packaging.Immediate visual inspection found that the sample had a small hole in the device cuff.Leak testing of the sample also detected leakage from the cuff.To further investigate the issue, relevant documents were reviewed and deemed adequate.A review of the manufacturing process was also conducted and was considered adequate and correct.Based on the evidence and testing, the complaint was confirmed.The event problem source was traced to manufacturing relating to damaging the unit upon taking out some parylene flash.

• Brand Name: BIVONA PEDIATRIC TTS 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 HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 6526716
• MDR Text Key: 74024107
• Report Number: 3012307300-2017-00918
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006308
• UDI-Public: 15021312006308
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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: No Information
• Device Expiration Date: 09/29/2021
• Device Catalogue Number: 67P055
• Device Lot Number: 3296321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 07/10/2018
• Supplement Dates FDA Received: 09/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 24