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

Catalog Number 60PFSS45

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

Samples received: one sample was received on 09/jan/2017 from p/n: 60pfss45 l/n: unknown without its original packaging, inside a ziploc bag.Visual inspection: visual inspection was performed at 12" under normal lightning in order to detect any damage on the part.Results: it was observed that the sample was marked on the connector with number 2, no defects were found on sample.Dimensional inspection: the shaft length of the sample was measured with a calibrated caliper results: it was seen that the sample was within specifications.

Event Description

It was reported that there was no indication that there was an issue with the portex® bivona® uncuffed pediatric flextend¿ standard silicone tracheostomy tube and the patient had been fit and well prior to the event.According to the reporter, the patient decannulated themselves which resulted in an emergent tracheostomy tube change.No issues were observed when securing the device to the patient.

• Brand Name: BIVONA
• 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.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7510909
• MDR Text Key: 108151692
• Report Number: 3012307300-2018-10216
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312516791
• UDI-Public: 15021312516791
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 60PFSS45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention