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

Catalog Number 60SP035

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma 510(k): additional 510(k): k083641.Customer has not returned the device to the manufacturer for device evaluation.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

It was reported that the patient's parents could not remove the heat moisture exchanger (hme) from the hub of a portex® bivona® uncuffed pediatric tracheostomy tube.It was noted that the event resulted in "decannulation".No patient injury was reported.See mfr: 3012307300-2017-01052.

Manufacturer Narrative

One device was returned for evaluation.Functional testing of the device involved a taper gage check and found the components within dimensional specifications and that the insertion of the connector into the hme filter had no issues.It was indicated that the hme adapter would not separate from the connector if too much force was applied.A review of the device master record was performed and found to be complete.The investigation did not reveal any intrinsic manufacturing defects.Based on the evidence, the root cause was attributed to a user error, due to the user interfacing with the product in a manner inconsistent with the instructions for use.

• Brand Name: PORTEX® 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 MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6573171
• MDR Text Key: 75409821
• Report Number: 3012307300-2017-01053
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312000375
• UDI-Public: 15021312000375
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 60SP035
• Device Lot Number: 3166696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2016
• 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