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

Model Number	67PFS35
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the coiled wire had recoiled up into proximal side of the trach tube.This was noticed by patients mother before tube change.This could have been a danger as without reinforced coil wire, occlusion could have occurred.This was noted during the pre test and there was no injury or adverse affects to the patient.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: visual inspection of the returned device did not reveal any anomalies.There was no evidence that the coil moved.Custom flex tend devices are manufactured with a coil reinforced shaft that extends from the connector to the neck flange, which is the proximal end of the device.Standard flex tend products are manufactured with reinforced coil throughout the entire shaft.The reported problem could not be confirmed.No fault was found.No corrective actions are planned currently.The manufacturer regularly analyzes complaint data and trends and will take further actions accordingly.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: correction: no lot/serial number was provided, therefore the product manufacture or expiration date was unknown.

• Brand Name: BIVONA CUSTOMIZED 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14955814
• Report Number: 3012307300-2022-13108
• Device Sequence Number: 6953183
• Product Code: JOH
• UDI-Device Identifier: 10351688518613
• UDI-Public: 10351688518613
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: Lay User/Patient
• Device Model Number: 67PFS35
• Device Catalogue Number: 67PFS35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 05/11/2023
• 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