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

Model Number FT21IN50NGF104N

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported that the trach was deflating after insertion.Due to this, the trach was removed from the patient to be tested.Once the trach was removed, it was filled and left out to see if it would stay inflated.It did not.No patient harm was reported at this time.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three (3) product samples were received for evaluation.Visual and functional testing were performed.Visual inspection did not identify any anomalies.Functional testing found no leaks were detected in one of the returned samples.A slow inside leak was detected in two of the returned samples.The root cause of the reported issue was found to be insufficient adhesive inserted into the lumen above where the airway line is secured to the lumen on the two samples that leaked.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.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14492838
• MDR Text Key: 292591337
• Report Number: 3012307300-2022-09575
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517281057
• UDI-Public: 15019517281057
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FT21IN50NGF104N
• Device Catalogue Number: FT21IN50NGF104N
• Device Lot Number: GA025476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1