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

Model Number 67PFS35

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 303740853
• Report Number: 3012307300-2022-13108
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 10351688518613
• UDI-Public: 10351688518613
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1