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

Model Number	67PFPS45
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One sample was received to perform an investigation.A device history record (dhr) review could not be performed as the lot number was unknown.No information has been provided to date.A visual inspection of the obturator was performed at 12 inches from the device under normal lighting.It was observed that the obturator sleeve was not loose or deformed.The obturator sleeve was then moved from top to bottom as usual, and it was observed that the obturator curve appeared deformed.Functional testing of the obturator was performed for obturator alignment.The obturator did not pass the test.It was found to be out of specification.The reported problem was confirmed.Root cause of the reported problem was unable to be determined.The most probable root cause was that the obturator became damaged after it left the manufacturing facility as the obturators were 100 percent inspected after the bending operation to verify the angle was within specification.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that during a hospital pre-test of the tracheostomy tube, the plastic sheath on the obturator was moving backwards and forwards making it very difficult to pull the obturator away from the tube.No patient injury was reported.

• Brand Name: BIVONA FLEXTEND TTS PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY 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: 15456264
• Report Number: 3012307300-2022-19792
• Device Sequence Number: 12473106
• Product Code: JOH
• UDI-Device Identifier: 10351688518552
• UDI-Public: 10351688518552
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: 67PFPS45
• Device Catalogue Number: 67PFPS45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown