MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES NEO/PED FLEXTEND; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number 67PFSS40

Device Problem Leak/Splash (1354)

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

Event Date 11/16/2021

Event Type  malfunction  

Event Description

It was reported on medwatch (b)(4): ventilator alarming due to large leak/high inspiratory tidal volume.Trach cuff found to have only 1.5cc volume.Sec added.Soft trach ties adjusted and tightened.Scheduled respiratory treatments given without issue.Ventilation appears to be back to baseline.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

Manufacturer Narrative

Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No product sample was received; therefore, root cause could not be determined.No corrective actions were taken because complaint could not be duplicated due to product sample not being returned.

Event Description

It was reported that a ventilator was alarming due to large leak and high inspiratory tidal volume.Tracheostomy cuff found to have only 1.5cc of volume.Soft tracheostomy ties adjusted and tightened.Scheduled respiratory treatments given without issue.Ventilation appears to be back to baseline.No patient injury reported.

• Brand Name: BIVONA TUBES NEO/PED FLEXTEND
• Type of Device: TRACHEOSTOMY TUBE 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: 13441058
• MDR Text Key: 284974238
• Report Number: 3012307300-2022-02447
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 10351688518699
• UDI-Public: 10351688518699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2023

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: Health Professional
• Device Model Number: 67PFSS40
• Device Catalogue Number: 67PFSS40
• Device Lot Number: 4015533
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 09/12/2022; 12/12/2022
• Supplement Dates FDA Received: 11/19/2022; 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 MO
• Patient Sex: Male
• Patient Weight: 8 KG