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

Model Number	67N035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Event or Problem Description
It was reported that the tracheostomy tube was inserted into the patient and patient was decompensating.The tube was removed and found to be sticking and not inflating symmetrically.A different tracheostomy tube of the same size was inserted into the patient and the patient stabilized.The patient injury was resolved.
Event or Problem Description
No medical or surgical intervention was reported.
Additional Manufacturer Narrative
Other, other text: additional information b5 d4 catalog number, d5 h6 this mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review one (1) picture was attached and reviewed.Results: the attached picture showed a tube with the cuff inflated only one side.The reported failure mode was confirmed.No product was returned for analysis.If the product is returned, the complaint will be reopen for further investigation.No root cause can be determined from the picture submitted and no product was returned for analysis.No corrective actions were performed since the root cause cannot be determined from the picture provided.The manufacturer will continue monitoring this failure condition in this product for future escalation.

• Brand Name: SILICONE - BIVONA TUBES NEO/PED TTS
• 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: 13481178
• Report Number: 3012307300-2022-02897
• Device Sequence Number: 5462755
• Product Code: JOH
• UDI-Device Identifier: 15021312006223
• UDI-Public: 15021312006223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083641
• 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,Followup
• Report Date (Section B): 05/10/2023

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: 03/27/2024
• 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
• Supplement Date Received by Manufacturer: 05/07/2023
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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: Required Intervention
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 5 KG