MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE

Catalog Number 60SP035

Device Problem Unintended Movement (3026)

Patient Problem Extubate (2402)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and 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

User facility reported that during use of the device with patient, the tube became dislodged from the patient's stoma.Reporter stated that the patient was swiftly treated by the patient's parents and the tracheostomy tube was changed immediately.No permanent adverse effects to patient reported.

Manufacturer Narrative

Three portex bivona uncuffed neonatal and pediatric tracheostomy tubes were returned for evaluation.The customer reported that three devices contributed to five reported events.The customer returned three devices for evaluation, but it was not determined which device was associated with this reported occurrence; therefore, the evaluation of the three returned devices will be used for the medwatch.The devices were returned without their original packaging.Visual inspection found no damage on the devices and all devices were marked with an "x".All three devices underwent a dimensional inspection and all devices met specifications.A review of the manufacturing and quality process documents was conducted and found to be adequate.A review of the production floor was conducted and no findings were detected that could create the defect reported.Based on the evidence, the complaint was unable to be confirmed.There was no evidence found to suggest the event was caused from an intrinsic defect in the product.A device history review, relevant to the reported lot, did not find any non-conformities during manufacturing and the lot passed qa inspection prior to shipment.(b)(4).

• Brand Name: PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5689725
• MDR Text Key: 46252575
• Report Number: 2183502-2016-01120
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 05/27/2020
• Device Catalogue Number: 60SP035
• Device Lot Number: 2999286
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR