MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA FOME-CUF ADULT TRACHEOSTOMY TUBE WITH TALK ATTACHMENT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	855150
Medical Device Problem Codes	Deflation Problem (1149); Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign: report source: (b)(6).Manufacturing date: device released for distribution on date provided per review of the dhr.Device evaluation: one portex device was returned for investigation.The device had residue present throughout the aspiration tubing, under the balloon cuff, and it was noticed that the suction control connector component was missing.A leak test was performed on both the aspiration and balloon cuff airway lines to determine if a leak existed in either airway and leaks were present in both airways.Two holes were present in the red plug and visible when the plug was stretched length-wise.One hole was present on the aspiration airway tubing, and the tubing appeared to be pinched where the hole was located.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Devices are 100% inspected for leaks by manufacturing and a sample of each lot is leak tested by quality.Based on the investigation, the complaint allegation was confirmed.However, the investigation determined that the device did meet manufacturing specification when released for distribution and there was no manufacturing defect identified.The event problem source is listed as unknown.
Event or Problem Description
Information was received that a smiths medical portex bivona fome-cuf adult tracheostomy tube with talk attachment was in use with a patient at their home.It was reported "the aspiration probe was damaged by opening holes and the device to deflate the cuff had a hole, preventing it from remaining deflated".There were no adverse patient effects.

• Brand Name: PORTEX BIVONA FOME-CUF ADULT TRACHEOSTOMY TUBE WITH TALK ATTACHMENT
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8856953
• Report Number: 3012307300-2019-03955
• Device Sequence Number: 16826920
• Product Code: BTO
• UDI-Device Identifier: 15021312006889
• UDI-Public: 15021312006889
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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: Lay User/Patient
• Device Expiration Date: 07/28/2019
• Device Model Number: 855150
• Device Catalogue Number: 855150
• Device Lot Number: 2709536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1