MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA NEO/PED TRACHEOSTOMY TUBES; NEO AIRE CUF TUBE STRAIGHT FLANGE

Model Number	65SN035
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product (when the customer was changing the fixing band to another one), he noticed the flange was damaged.The customer did not use any sharp-edged tools such as scissors during the use of the product.No patient injury.There is no other information available for this complaint.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.Three photos were included for evaluation, photos showed eyelet broken.A product sample was received for evaluation.The sample was received in used condition without the original packaging.The sample was visually inspected under normal conditions of illumination to detect any conditions that could cause functional issues.Eyelet broken was found, complaint was confirmed.Process controls are in place for this failure mode, cuff won?t inflate.Cuffs are 100 percent visually inspected by production personnel.Quality inspectors take a representative sample of the lot and performs visual inspection.Based on the analysis conducted in the sample provided, failure mode was confirmed.According to on procedure, the occurrence of this failure mode could be caused by mishandling during unload.A customer complaint notification was made to production personnel to explain the importance to adherence or following in the manufacturing procedure.

• Brand Name: BIVONA NEO/PED TRACHEOSTOMY TUBES
• Common Device Name: NEO AIRE CUF TUBE STRAIGHT FLANGE
• 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; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 14797045
• Report Number: 3012307300-2022-12426
• Device Sequence Number: 6108399
• Product Code: JOH
• UDI-Device Identifier: 15021312000061
• UDI-Public: 15021312000061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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 Expiration Date: 01/27/2026
• Device Model Number: 65SN035
• Device Catalogue Number: 65SN035
• Device Lot Number: 4107576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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