MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBES

Model Number	67N035
Medical Device Problem Codes	Inflation Problem (1310); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.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 re-open this complaint for further investigation.
Event or Problem Description
It was reported that the patient has three trachs of same item and lot number.One trach was inserted into the patient and the patient was decompensating.The trach was removed and found to be sticking and not inflating symmetrically.The other two trachs were tested outside of the patient and the same issue was found.Additional information reported that a different bivona of the same size was inserted into the patient and the patient stabilized.There were no reports of patient harm or impact associated with the reported event.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBES
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16861423
• Report Number: 3012307300-2023-04975
• Device Sequence Number: 5957976
• Product Code: JOH
• UDI-Device Identifier: 15021312006223
• UDI-Public: 15021312006223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083641, K94
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 67N035
• Device Catalogue Number: 67N035
• Device Lot Number: 3797645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 05/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 5 KG