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

Catalog Number	67P045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex® bivona® neonatal and pediatric tts¿ (tight-to-shaft) tracheostomy tube does not work.There was no reported adverse patient effects.
Additional Manufacturer Narrative
One portex® bivona® neonatal and pediatric tts¿ (tight-to-shaft) tracheostomy tubes was received.The device was inspected at 12" under normal lighting, in order to detect any damage on the cuffs, airline or pivot balloon.An air cuff symmetry test was performed on the device.When inflating the device with air, it was observed that the part was not inflated uniformly.In accordance with the ifu, the cuff was manipulated and the whole cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times.During each attempt the cuff inflated completely.When measuring the cuff, the percentage for the symmetry was 44.44%.This result was over the 33.3% that is the minimum acceptable value.Based on this test, the device was considered to have operated within specification.A review of the manufacturing process for the device was conducted by a quality intern on 04/may/2018 in order to verify that there were no situations or practices that could have created a non-conformance.All the procedures were carried out appropriately.In addition, during the verification, 32 assemblies were reviewed to see the complete manufacturing process of the air way and balloon.Once the units were assembled, they were inflated with air and visually inspected 100% to see that the cuff inflated uniformly.It was observed that the air cuff symmetry test was correctly performed.There is no root cause for this event since the complaint was not confirmed.No corrective actions are required since the complaint was not confirmed.As a preventive action the production personnel were notified by the area trainer on 15/may/2018 of the defect reported by the customer.

• Brand Name: PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) 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: 7270243
• Report Number: 3012307300-2018-00271
• Device Sequence Number: 1847391
• Product Code: JOH
• UDI-Device Identifier: 15021312006285
• UDI-Public: 15021312006285
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,user facilit
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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: No Information
• Device Expiration Date: 06/07/2022
• Device Catalogue Number: 67P045
• Device Lot Number: 3445519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1