MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC TRACHEOSTOMY SILICONE - BIVONA TUBES CUSTOM; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	CUSTOM 7.0 FLEXTEND TTS NS
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Tear, Rip or Hole in Device Packaging (2385); Scratched Material (3020)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smith medical custom trach was inserted on (b)(6) 2020 and developed a hole in the cuff on the evening of (b)(6) 2020 ,which was making the patient continuously cough.A new trach was placed and the following day developed a hole in the cuff as well.This event of coughing would increase secretions of phlegm, which may put the patient at risk for aspiration of secretions and further obstruction.No injury was reported.
Additional Manufacturer Narrative
Three bivona custom tracheostomy tubes were returned for analysis.Leak testing was performed using magnification.Abrasion marks were observed surrounding the leak location on each device.Water was then inserted into the inflation system to find the exact location.A verified ruler (blue dot) was performed and the distance from the leak location to the distal tip and the distance from the edge of the shaft were measured.The following are the measurements for the hole on the three trach tubes: device #1: 20 mm from tip and 6 mm from edge of tube on end user's right side when in situ device #2: 19 mm from tip and 6 mm from edge of tube on end user's right side when in situ device #3: 20 mm from tip and 6 mm from edge of tube on end user's right side when in situ it is believed that there is something (e.G.Bone spur, cartilage) in the trachea that is contacting the cuff.Based on the evidence, the complaint is confirmed.However, the root cause is unknown.

• Brand Name: TRACHEOSTOMY SILICONE - BIVONA TUBES CUSTOM
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 lane n; minneapolis, mn
• MDR Report Key: 10260507
• Report Number: 3012307300-2020-07165
• Device Sequence Number: 3749548
• Product Code: JOH
• UDI-Device Identifier: 15019517212228
• UDI-Public: 15019517212228
• Combination Product (Y/N): N
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/11/2025
• Device Model Number: CUSTOM 7.0 FLEXTEND TTS NS
• Device Catalogue Number: XT19KS70NSC923N
• Device Lot Number: SS028877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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