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

Model Number	ZZ19LN85ZZZ016N
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a pressure point due to fold on the foam cuff.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: a customer response was attached to the complaint.(updated b5, h6), corrected data: e1 - email and phone number switched.
Event or Problem Description
Additional information received via e-mail on (b)(6)-2022: the pressure point caused of the cannula was noticed by the healthcare professional (homecare provider) during the trach change.The wound did not require any surgical treatment; it was sufficient to cover the area and provide pressure relief.To relieve the pressure, the upper cuff was not completely filled with air.During this, speaking was significantly limited and the wound was painful.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H10: 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 was performed.Visual inspection found a slight crease / fold / bagginess in the cuff.This crease / fold / bagginess disappeared when inserting 3 cc of air into the cuff.Functional testing found no manufacturing defect was determined with the returned device.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15057710
• Report Number: 3012307300-2022-13674
• Device Sequence Number: 14787009
• Product Code: JOH
• UDI-Device Identifier: 15019517213713
• UDI-Public: 15019517213713
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2023

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: ZZ19LN85ZZZ016N
• Device Catalogue Number: ZZ19LN85ZZZ016N
• Device Lot Number: GA027104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 04/11/2023
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 10/04/2022; 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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