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

Model Number	FT18GN35NGF032N
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the pilot balloon to a smiths medical portex bivona customized flextend tracheostomy tube was noted to have a hole.Subsequently, a trach tube change out was performed and the issue resolved.There were no reported adverse patient effects.
Additional Manufacturer Narrative
Other, other text: device evaluation: portex bivona customized flextend tracheostomy tube returned to analysis.According to the investigation visual inspection showed a cut on the airway line.Functional testing was performed by using a syringe, 5cc of air was inserted into the inflation valve and the cuff did not inflate.Investigator?s also performed leak test per (b)(4) and this confirmed that the only location where the device leaked was via the cut on the airway line.According to the investigation the customer?s reported problem was confirmed.However, since the device was successfully used for a period of time, the investigation determined that the airway line had been cut after it had been packaged.No corrective actions are planned at this time.Smith?s medical regularly analyzes complaint data and trends and will take further actions accordingly.The problem source of the reported problem is user interface.

• Brand Name: PORTEX BIVONA CUSTOMIZED FLEXTEND TRACHEOSTOMY TUB
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10171100
• Report Number: 3012307300-2020-06057
• Device Sequence Number: 2142898
• Product Code: JOH
• UDI-Device Identifier: 15019517157697
• UDI-Public: 15019517157697
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: FT18GN35NGF032N
• Device Catalogue Number: FT18GN35NGF032N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 10