MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA NEONATAL AND PEDIATRIC TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 67SN040

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2018

Event Type  malfunction  

Event Description

Information was received indicating that a patient with a smiths medical portex® bivona® tts¿ (tight-to-shaft) tracheostomy tube was brought to magnetic resonance imaging (mri).It was reported that the patient was grabbing at their throat and the tube had started to come out.Subsequently, the trach was changed out for an mri safe trach and was discarded.The packaging of the tube was noted not to state that the tube was mri "conditional" as the website states it should be.The patient recovered with no adverse effects.

Manufacturer Narrative

Device evaluation: one smiths medical cadd cassette reservoir was returned for analysis in a used condition.During analysis, functional testing was performed, a syringe was used to infuse water into the assembly (ay) bag and leak was detected in the ay bag specifically located on the top corner near pump tube connection.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted t be manufacturing.

• Brand Name: PORTEX BIVONA NEONATAL AND PEDIATRIC TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8238561
• MDR Text Key: 132762323
• Report Number: 3012307300-2019-00214
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312000269
• UDI-Public: 15021312000269
• Combination Product (y/n): N
• PMA/PMN Number: K914088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2019
• Device Model Number: 67SN040
• Device Catalogue Number: 67SN040
• Device Lot Number: 2643556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention