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

Model Number	FP16KN40NGA049S
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the custom trach that was ordered 2 years ago was discovered to be faulty when it was opened.It was not able to be fitted to the child.No patient injury was reported.
Additional Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be completed.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 information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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): 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: 15460055
• Report Number: 3012307300-2022-19906
• Device Sequence Number: 16862397
• Product Code: JOH
• UDI-Device Identifier: 15019517083767
• UDI-Public: 15019517083767
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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 Model Number: FP16KN40NGA049S
• Device Catalogue Number: FP16KN40NGA049S
• Device Lot Number: DS001146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown