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

Model Number	FT19DN50NSA006N
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a smiths medical portex bivona flextend¿ tracheostomy tube was reported to be tilted in the middle with possibility of wrong id size.It was also reported that the obturator was difficult to slide in and out along with the suction catheter getting stuck.The tube was removed with no reported adverse effects.
Additional Manufacturer Narrative
Additional information was received from the customer that the patient has been a tracheostomy dependent patient with bipap dependence.It was reported that the trach tube appeared to be the wrong size as when the 10fr catheter was used to suction the patient, it was very tight and could not slide through easily.The trach tube was noted to be "tilted" in the middle.The mom noted that this tilt in the middle had caused coughing and aspiration.The tube was removed and replaced with another trach tube.Two flextend tracheostomy tubes were returned for analysis.Visual inspection of both returned devices did not reveal a large sharp piece of plastic in either of the samples.A tiny drop of silicone adhesive was found on the cuff that was missed during quality inspection prior to release of the samples.The obturators were inserted; no discrepancies as it easily slid in and out of the tube.A catheter was then inserted and was observed to move easily in and out of the shafts.Visual inspection of the devices did not easily identify the tilting referenced in the complaint description.The neck flange on one device was determined not to be perfectly perpendicular due to the airway insertion.As a result, the neck flange orientation caused a slight twist to the shaft, which the end user was not able to tolerate.Based on the evidence, the complaint was confirmed with the root cause stemming from manufacturing.Updated fields: a1, a2, a3, b7, and d10.

• Brand Name: PORTEX BIVONA FLEXTEND TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9584437
• Report Number: 3012307300-2020-00250
• Device Sequence Number: 16266218
• Product Code: JOH
• UDI-Device Identifier: 15019517186833
• UDI-Public: 15019517186833
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 03/04/2020

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: No Information
• Device Expiration Date: 12/02/2024
• Device Model Number: FT19DN50NSA006N
• Device Catalogue Number: FT19DN50NSA006N
• Device Lot Number: BS002104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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
• Patient Age: 6 YR