MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67P045
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
See mfr: 3012307300-2017-01593, 3012307300-2017-01734, and 3012307300-2017-01736 (same patient).Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a portex® bivona® pediatric tts¿ (tight-to-shaft) tracheostomy tube was not inflating properly.The cuff would only expand on one side of the shaft, and would deflate after being inserted.The patient had a respiratory event, possibly due to the failure with the tracheostomy tube had a resuscitation bag applied and was transported to the hospital, where the patient was admitted.It was later reported that the patient expired due to complications.
Additional Manufacturer Narrative
The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.A review of manufacturing documents was performed and was found to be adequate and correct in terms of relevant testing and inspection activities.Prior to release for distribution, a 100 percent air cuff symmetry visual inspection is performed.One used sample was received for evaluation.It could not be determined which device was associated with the reported event; therefore, the evaluation of the returned device will be used for the medwatch.Visual inspection was performed and found no discrepancies.Functional testing was performed to detect for any cuff symmetry issues.Upon inflation of the cuff with air, it was observed that one half of the cuff inflated as expected and the other half did not inflate.Subsequently, the cuff was manipulated and it was able to inflate properly.Then, the cuff was deflated and inflated an additional four times successfully.On measurement, the symmetry was found to be 50 percent; this result is greater than the 33.3 percent acceptance rate.Based on this testing, the device was found to be within specification.The complaint could not be confirmed.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® PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) 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: 6757967
• Report Number: 3012307300-2017-01735
• Device Sequence Number: 1723516
• Product Code: JOH
• UDI-Device Identifier: 15021312006285
• UDI-Public: 15021312006285
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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: No Information
• Device Expiration Date: 10/18/2021
• Device Catalogue Number: 67P045
• Device Lot Number: 3296332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 10/18/2017
• 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: BREAS VIVO 50 VENTILATOR
• Outcome Attributed to Adverse Event: Death
• Patient Weight: 8