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

Model Number	XT18ES50NSC980N
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Tachycardia (2095); Low Oxygen Saturation (2477)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One bivona flextend was returned for analysis.Leak testing was performed; noting pinhole and slow leak from the cuff.All assembled parts are required to pass leak tests at two steps in the operation prior to being shipped to the customer.Additionally, there is no correspondence from the customer describing whether leakage was noted on the first use of the product or after reprocessing, etc.Based on the evidence, the complaint was confirmed.However, the root cause is unknown.
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube was found leaking upon assessing the patient's drop-in oxygen saturation level.The cuff was re-inflated with 3mls of water and was later checked to find only 0.5mls of water left.Mother stated that the ent and respiratory therapy were notified with instruction to re-inflate the cuff with water when needed until the replacement trach tube arrived.The trach tube was eventually changed out.It was reported that part of the wedge used to remove the tube had caused a mucous plug which was relieved by suctioning.The patient's mother reported an elevated heart rate at that time but then resolved.There were no further reported adverse 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 n; minneapolis,, mn
• MDR Report Key: 9925316
• Report Number: 3012307300-2020-02691
• Device Sequence Number: 3329761
• Product Code: JOH
• UDI-Device Identifier: 15019517150650
• UDI-Public: 15019517150650
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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 Model Number: XT18ES50NSC980N
• Device Catalogue Number: XT18ES50NSC980N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 04/03/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 14 YR