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

Model Number	FU20AN55NSZ017N
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
There is a tiny spur of plastic right at the end of the trach tube.No patient injury.
Event or Problem Description
There is a tiny spur of plastic right at the end of the trach tube.No patient injury.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the two returned devices showed that one of the devices had an adhesive drip at the distal tip where the lumen had been backfilled.No foreign piece of plastic was confirmed.Using magnification on an sz30 olympus microscope to aid in measuring the drip, the drip extended 0.5 mm past the end of the tip and measured between 1.5 and 1.0 square mm (circle mark) on the tappi dirt estimation chart (purple verification dot).No other defects were identified with the device, and no defects were identified with the other device.The reported problem was confirmed.The cause of the reported problem was traced to the manufacturing process.No adverse trends have been identified related to this issue.A quality alert, qa22-002, was issued to the custom lab heightening the awareness on workmanship, and the drawing was updated to include a note highlighting that the tip is to be beveled and free of adhesive drips.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the dhr.

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13584803
• Report Number: 3012307300-2022-03921
• Device Sequence Number: 5644536
• Product Code: JOH
• UDI-Device Identifier: 15019517216349
• UDI-Public: 15019517216349
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 03/29/2022

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 Model Number: FU20AN55NSZ017N
• Device Catalogue Number: FU20AN55NSZ017N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown