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

Model Number	FT19BN50NGA037N
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related to mfr number: 3012307300-2019-04253 (same patient with two same device issues).
Event or Problem Description
Information was received that a smiths medical bivona custom flextend tracheostomy tube was in use with a patient on a ventilator of an unknown brand at their home.It was reported the patient's ventilator would not stop alarming, so the patient's mother tried suctioning the tube to see if it would resolve the alarm.When the alarming continued, the tracheostomy (trach) tube was removed and found to have a hole in it.A new trach was inserted, but the ventilator kept alarming.Subsequently, the patient's second trach was taken out and was found to have a hole in it as well.When a third trach was placed into the patient, the ventilator alarming resolved.There were no adverse patient effects.
Additional Manufacturer Narrative
Evaluation results: one bivona tracheostomy was received in used condition.Visual inspection found no non-conformities.A leak test was preformed and a leak was found where the airway line is secured to the neck flange.The amount of adhesive applied to secure the airway line adequately met the manufacturing requirements.It is likely that the airway line was pulled during use, causing the airway line to tear from the neck flange.Since no lot number was provided, a review of the device history review (dhr) was performed for the two most recent orders.The review showed that the products had passed all required inspections, including a 200% leak test.The product problem does not appear to be a manufacturing issue.

• Brand Name: BIVONA CUSTOM FLEXTEND 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: 8906632
• Report Number: 3012307300-2019-04252
• Device Sequence Number: 16781378
• Product Code: JOH
• UDI-Device Identifier: 15019517180930
• UDI-Public: 15019517180930
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: Lay User/Patient
• Device Model Number: FT19BN50NGA037N
• Device Catalogue Number: FT19BN50NGA037N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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
• Patient Age: 11 YR