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

Model Number	60P035
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was found one (1) sample was received with its certificate of decontamination, in used conditions, without its original pakaging inside a ziploc bag.Also a catheter was received inside its original package.Visual inspection was performed at 12? under normal conditions of illumination in order to detect any damage on the part.Sample was visually inspected to see if the assembly meet the half moon specification.During the visual inspection, it was seen that the assembly is within spec (the id is concentric).Functional testing: the catheter was introduced inside the tube starting from the connector to the tube tip to see if there was problem to introduce the catheter.The catheter did not easily pass through the tube bore.Resistance to introduce the catheter was found during the test.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This mdr was generated under protocol (b)(4).This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that a trach change was about to be done when it was found that the new trach tube had resistance when passing the suction catheter.The trach tube was not used, and an alternate trach tube was used instead.No patient injury reported.

• Brand Name: BIVONA
• 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: 15280321
• Report Number: 3012307300-2022-15963
• Device Sequence Number: 20617787
• Product Code: JOH
• UDI-Device Identifier: 15021312005745
• UDI-Public: 15021312005745
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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: 60P035
• Device Catalogue Number: 60P035
• Device Lot Number: 3051819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• Initial Report FDA Received Date: 08/23/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown