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

Catalog Number	FP19AN35NSE099N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Upon visual inspection, device was found to be in good physical condition.Device underwent leak testing, and the customer reported complaint was confirmed.A leak was noted where airway inserts into the neck strap.The adhesive located around the area appeared to be peeled away from the shaft of the product.Sufficient adhesive was present around the inflation line/ neck strap junction.It was determined the cause of the issue was likely pulling the airway line, simultaneously pulling the adhesive away from the shaft.
Event or Problem Description
It was reported that after one week of use of a smiths medical tracheostomy tube, a pop and audible leak was heard from the patient.The pilot balloon was noted to have air coming out the end.A tracheostomy tube change out was done, resulting in no harm to the patient.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Visual inspection of the device found it to be in good physical condition.The device underwent leak testing, and a leak was noted to be occurring where the airway inserts in to the neck strap.Additionally, the adhesive located around the area appeared to be peeled away from the shaft of the product.The most likely cause of issue was the airway line adhesive was pulled away from the shaft.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX® BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• 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: 8441436
• Report Number: 3012307300-2019-01445
• Device Sequence Number: 14217137
• Product Code: JOH
• UDI-Device Identifier: 15019517179101
• UDI-Public: 15019517179101
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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 Catalogue Number: FP19AN35NSE099N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VENTILATOR; VENTILATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 MO