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

Model Number 67NFPS40

Device Problem Leak/Splash (1354)

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

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the cuff is leaking.No injury, no patient involvement reported.

Manufacturer Narrative

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 no damage could be detected.Functional testing found the cuff inflated successfully; the complaint was not confirmed.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 TUBES NEO/PED FLEXTEND
• 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: 15870097
• MDR Text Key: 307497358
• Report Number: 3012307300-2022-27479
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 10351688518804
• UDI-Public: 10351688518804
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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: 67NFPS40
• Device Catalogue Number: 67NFPS40
• Device Lot Number: 3962592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1