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

Model Number FT21HN40NGE133N

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

No device was returned for investigation.If the device is received the investigation will be reopened.

Event Description

It was reported that the device leaks from the inside at the adapter end.No additional information.

Manufacturer Narrative

Additional information received.Updated section b3.

Manufacturer Narrative

Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found did not reveal any anomalies.Functional testing found a slow, inside leak was detected at the lumen by the connector.The investigation determined that there was insufficient adhesive inserted into the lumen above where the airway line is secured to the lumen.Root cause was determined to be manufacturing.To heighten awareness, a quality alert was issued to the production floor for custom lab operator review.

• Brand Name: BIVONA
• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14355854
• MDR Text Key: 291385098
• Report Number: 3012307300-2022-08504
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517279122
• UDI-Public: 15019517279122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

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
• Device Operator: Other
• Device Model Number: FT21HN40NGE133N
• Device Catalogue Number: FT21HN40NGE133N
• Device Lot Number: GA02654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 05/20/2022; 07/05/2022
• Supplement Dates FDA Received: 06/14/2022; 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Sex: Female