MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA TTS CUFFED PEDIATRIC WITH V NECK FLANGE TRACHEOSTOMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67P030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical portex bivona tts cuffed pediatric with v neck flange tracheostomy tube cuff balloon would not inflate while in use with a nicu patient.Subsequently, a tracheostomy change out was required.There were no adverse patient effects.
Additional Manufacturer Narrative
Device evaluation: one tracheostomy was returned for evaluation.Visual inspection of the device found white particles inside the cuff.The unit was inflated with 5cc of air in order to see if there was any problem to inflate the cuff.When inflating the unit, it was seen that pilot balloon inflated but all air was stuck in it.According to the ifu the balloon was manipulated and the whole cuff inflated.After the whole cuff inflated, it was tried to deflate it but it was difficult.After the cuff was deflated, it was inflated again with 5cc of air.During the inflation, it was seen that the air passed through the inflation line slowly and when it was tried to deflate the cuff it was difficult to do it.The inflation line was visually inspected to see if it is blocked.During the visual inspection, it was seen that the line was blocked by a white substance.Then the cuff was burst and it was used a syringe to pass air through the inflation line.When the air was passing through the inflation line a small particle came off from the inflation line.After, it was passed air again through the inflation line.This time the air did not stuck in the inflation line, the air passed without difficult.The reported customer complaint was confirmed.And while no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• Brand Name: PORTEX BIVONA TTS CUFFED PEDIATRIC WITH V NECK FLANGE TRACHEOSTOMY
• 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: 8465787
• Report Number: 3012307300-2019-01684
• Device Sequence Number: 16479173
• Product Code: JOH
• UDI-Device Identifier: 15021312006254
• UDI-Public: 15021312006254
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• 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): 06/19/2019

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: 07/18/2022
• Device Model Number: 67P030
• Device Catalogue Number: 67P030
• Device Lot Number: 3472136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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