MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 60P050

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

The tracheostomy tube is for single patient use, but can be used multiple times on the same patient.

Event Description

It was reported that the tube was torn off when the patient was moving about while using a bivona® uncuffed pediatric tracheostomy tube.There were no patient adverse events.

Manufacturer Narrative

One device was returned for evaluation without its original packaging.Visual inspection of the device found a split on the flange eyelet.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies.A review of 32 assemblies on the line was performed for molding issues and did not detect any damage.An attempt to reproduce the failure mode was performed by making a small cut on the inside and outside and pulled with a twill tape cut.Based on the evidence, a root cause was unable to be confirmed.It was determined that the most probable root cause is that damaged occurred after the device left the manufacturing facility.

• Brand Name: BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no. 4; parque industrial internaciona; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7042605
• MDR Text Key: 93093901
• Report Number: 3012307300-2017-02421
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312005776
• UDI-Public: 15021312005776
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: 60P050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1