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

Model Number	FT19CN45NGF923N
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Previous information from the reporter stated all three issues with this patient were found prior to use.However, additional information was received on 11sep19 via telephone: the reporter confirmed that there were still six total occurrences for three patients.However, they clarified that three instead of four incidents occurred for an identified dp male patient (one serious injury tube change out (captured in this specific report), and two events found prior to use instead of three).They also stated two incidents (instead of one) occurred with a second (unknown gender) ct patient while in use, and one instance occurred for the third unidentified patient.The reporter could not provide information for two of the three patients (patient ct and unidentified patient) on which specific events corresponded to each patient.Therefore, the following mfrs will be related to capture four events that occurred while in use with three different patients from this same reporter: 3012307300-2019-04596, 3012307300-2019-04597, 3012307300-2019-04598, and 3012307300-2019-05276.No further information is available.Device evaluation: three portex samples were returned for investigation.Immediately upon receipt of the product, the customer's reported complaint with the devices was confirmed.There was damage to the connector "ribs" and the rigid plastic part was separating from the flexible silicone portion.This type of damage has not been previously noted in customer complaints to this investigation site.Therefore, the legal manufacturer and location where the connector subcomponent was manufactured (smiths-medical in gary, in) was consulted and the parts were sent back to them for further evaluation.The investigation team was unable to find any marks on the product that would identify the reported event problem source.Additionally, the subcomponent dhr documentation was reviewed and there was no evidence of a related issue.It was also noted that devices are subject to 100% inspection prior to shipment.Based on further investigation with the legal manufacturer, it was concluded that this damage was likely caused in the field after it was shipped from the smiths-medical facility.
Event or Problem Description
Information was received that a smiths medical portex bivona flextend tts tracheostomy tube had issues with the hub and was reported to be cracking and pulling away from the tube.The reporter also stated that when looking at the other two devices their box, they "noticed that the plastic pieces inside the hubs were cracked".Subsequently, a tube change out was required.There were no adverse patient effects.

• Brand Name: PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE
• 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: 9168108
• Report Number: 3012307300-2019-05276
• Device Sequence Number: 2692771
• Product Code: JOH
• UDI-Device Identifier: 15019517186055
• UDI-Public: 15019517186055
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 03/26/2024
• Device Model Number: FT19CN45NGF923N
• Device Catalogue Number: FT19CN45NGF923N
• Device Lot Number: SS020876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention