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	08/04/2019
Type of Reportable Event	Serious Injury
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.Subsequently, a tube change out was required.There were no adverse patient effects.
Additional Manufacturer Narrative
Additional information: per the complaint notification on 11aug19, the reporter stated the following: "three patients in the past 4 weeks that have had similar problems.We decided to report it after we noticed the issues with the hubs on the third patient.I believe it was august 4th when we discovered a problem at the hub with the third patient.His trach was changed out that day.At that time, we looked through his trachs closer and noticed that there were three hubs with the same problem.As far as the other trachs that we did not report, one tore away between the hub and the silicone portion of the trach.We changed it out immediately.This trach was in an older teen that does not move around much at all.The other trach had similar damage to the three that we reported, this patient doesn't move around at all".Patient identifiers were also provided for one patient, who was noted to be male and had issues prior to use.Therefore, six occurrences for three patients were documented in the following way: occurrences one-four: 0048916 (mfr number- 3012307300-2019-04596): one instance of one patient with a tube change out serious injury and three instances of devices found prior to use (these three events found prior to use are not reportable).Occurrence five: 0048928 (mfr number- 3012307300-2019-04597): one malfunction instance of one patient (unknown identifiers) having "issues with the hub and was reported to be cracking and pulling away from the tube" and "does not move around much at all".Occurrence six: 0048932 (mfr number- 3012307300-2019-04598): one instance of one patient (unknown identifiers) with a tube change out serious injury where the device "tore away between the hub and the silicone portion of the tracheostomy (trach) tube and was changed out immediately" and also the "trach was in an older teen that did not move around much at all".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, and two events found prior to use).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.The gender for this patient/file event is now unknown due to the additional information provided from 11sep19.No further information is available.

• 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: 8946962
• Report Number: 3012307300-2019-04596
• Device Sequence Number: 19354811
• 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,Followup
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement 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