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

Model Number	FT17AN40NGF950N
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Decreased Respiratory Rate (2485); Respiratory Insufficiency (4462)
Date of Event	03/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other text: d4: lot number, expiration date and h4: device manufacture date is unknown, no information has been provided to date.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 or Problem Description
It was reported that the tracheostomy was out of patient's neck.Upon inspection it was found that the flange loop on trach broke allowing trach ties to become disconnected.The patient was then able to pull the trach out causing desaturations and bradycardia due to loss of airway.A new, emergency trach was inserted, and patient recovered.During trach care while the nurse was tying trach ties to secure the trach, a snap noise was heard and noticed the trach flange had split and broken; an unplanned trach change was performed.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.Device evaluation: five used tracheostomy devices without packaging were returned for analysis (3 of part# ft17an40ngf950n, 1 of part# ft17an35ngf951n and one part# unknown).Based on information provided by the complainant, it was determined that four devices with known part numbers were built at the southington facility and the remaining device with unknown part number was highly probable to have been built at the tijuana facility.The devices were visually examined for potential nonconformances, with four out of five samples displaying evidence of damaged and/or torn eyelet(s) on the neck flanges.The observed damage and tears in the neck flange eyelets is consistent with the use of a sharp-edged tube holder.Based on device analysis, the complaint cannot be confirmed as a manufacturing nonconformance, but is highly probable to have been caused by a variation in user technique.No correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.No lot number was provided.Therefore no device history report (dhr) review could be performed.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17010559
• Report Number: 3012307300-2023-05734
• Device Sequence Number: 6975888
• Product Code: JOH
• UDI-Device Identifier: 15019517091403
• UDI-Public: 15019517091403
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: FT17AN40NGF950N
• Device Catalogue Number: FT17AN40NGF950N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown