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

Model Number	ST19JN80NSC109N
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes custom cuff deflated when placed in patient with 9 ml filled and when the parent administered nebulizer, they heard leaking sound, so tube change out was required with no further adverse patient events.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.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.
Event or Problem Description
Additional info received 19 may 2021: additional file needed.Same issue, same patient.

• 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11974795
• Report Number: 3012307300-2021-05836
• Device Sequence Number: 11753525
• Product Code: JOH
• UDI-Device Identifier: 15019517208917
• UDI-Public: 15019517208917
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2025
• Device Model Number: ST19JN80NSC109N
• Device Catalogue Number: ST19JN80NSC109N
• Device Lot Number: BS011239
• 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: 05/13/2021
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown