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

Catalog Number	FT18DN35NGF006N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube leaked 0.2mls following by another 0.2mls over the next 12 hours.Subsequently, the backup tracheostomy (trach) was required to be placed.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One infusion pump was returned for evaluation.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.Visual inspection of the pump found it be damaged with cracked front and rear housing.The device was powered up and alarmed ec 1260 and ec 1261, confirming the customer's complaint.The root cause of the complaint was determined to be the circuit board which was then replaced.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES
• 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: 7918521
• Report Number: 3012307300-2018-04144
• Device Sequence Number: 1682463
• Product Code: JOH
• UDI-Device Identifier: 15019517146264
• UDI-Public: 15019517146264
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 09/28/2018

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 Catalogue Number: FT18DN35NGF006N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: Life Threatening; Required Intervention