MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	SU15CN40NSB189S
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the reporter noted the device "lasted till the second week of (b)(6) 2017." 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 or Problem Description
It was reported that a portex® bivona® custom neonatal and pediatric tracheostomy tube eyelet broke, the tracheostomy tube fell apart, and the tube fell out.The incident was observed by the patient's mother and the home healthcare nurse.The tracheostomy tube was in use for 6-8 weeks before the eyelet broke.It was noted that velcro ties were used to hold the tracheostomy tube in place.The ties were changed once a day after the patient was bathed.The tracheostomy tube was fixed by the patient's mother by "sewing it" to address the issue.No patient injury was reported.See mfr: 3012307300-2017-00581, 3012307300-2017-00582, and 3012307300-2017-00583.

• Brand Name: PORTEX® BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6365445
• Report Number: 3012307300-2017-00584
• Device Sequence Number: 13696887
• Product Code: JOH
• UDI-Device Identifier: 10351688848161
• UDI-Public: 10351688848161
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Patient Family Member or Friend
• Device Expiration Date: 03/08/2021
• Device Catalogue Number: SU15CN40NSB189S
• Device Lot Number: GS022240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 15