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

Catalog Number	FT18FN50NGF034N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	09/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex bivona flextend¿ tracheostomy tube was unable to be filled with water.There were no reported adverse patient effects.
Additional Manufacturer Narrative
Evaluation results: one bivona tracheostomy custom tube (5.0 mm) was returned for investigation.The device and obturator were returned along with the tyvek lid.The lot number was 345851.The investigator noted that the aforementioned part number and lot number were different than the one reported in the complaint.The device was returned for because the customer was unable to inflate the cuff with water.The device was leak tested by injecting it with 7 cc's of air.The device inflated and deflated with no difficulties.The device was then leak tested by injecting 7 cc's of water inside the cuff.Once again the device inflated and deflated with no difficulties.The customer reported product problem was not replicated.A root cause could not be established.
Additional Manufacturer Narrative
Additional information was received indicating that the product problem was discovered prior to use on the patient.The product problem was observed on 15 - september -2019.The patient's mother noted that she was unable to perform a trach change out as a result of the product problem.No patient injury or complications were reported as a direct result of the product problem.Updated fields: event date recorded.Device return date recorded.Device evaluation in progress.Patient code: 2645 recorded.Method: 4118 recorded.Results: 3221 recorded.Conclusion: 11 recorded.

• Brand Name: PORTEX BIVONA FLEXTEND TRACHEOSTOMY TUBE
• Common Device Name: PORTEX BIVONA FLEXTEND¿ TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9204940
• Report Number: 3012307300-2019-05687
• Device Sequence Number: 3146443
• Product Code: JOH
• UDI-Device Identifier: 15019517154603
• UDI-Public: 15019517154603
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/26/2024
• Device Catalogue Number: FT18FN50NGF034N
• Device Lot Number: DS025447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/28/2019; 11/07/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/07/2019; 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1