MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND TTS PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67PFS40
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Airway Obstruction (1699); Bradycardia (1751); Cyanosis (1798); Hypoxia (1918)
Date of Event	04/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Initial reporter sent report to fda is unknown.No product information has been provided to date.
Event or Problem Description
It was reported that the child had a history of ondine's syndrome and was ventilated during sleep via a tracheostomy tube.The patient was admitted to the department for a re-evaluation.At 8:30 in the morning, the professionals heard the ventilator alarm and observed that the ventilator was disconnected from the tracheostomy tube.The child was non reactive with blue lips, heart rate 37 and 7 percent oxygen saturation (spo2).Resuscitation was initiated.Ventilation was performed with a one-way valve self-filling balloon until help arrived.The cannula was blocked and suction was not possible.The cannula was changed and recovery of 100 percent spo2 and 80 cf occurred quickly with some insufflations.Additional information received indicated that the patient's status was recovered.The institution analyzed the situation and found that the main contributing factor was the lack of reporting of alarms from the patient's ventilator, which did not allow for rapid identification of the incident.

• Brand Name: BIVONA FLEXTEND TTS PEDIATRIC TRACHEOSTOMY TUBE
• 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: 14699385
• Report Number: 3012307300-2022-11664
• Device Sequence Number: 5176180
• Product Code: JOH
• UDI-Device Identifier: 10351688518620
• UDI-Public: 10351688518620
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2022

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: 67PFS40
• Device Catalogue Number: 67PFS40
• 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: 05/16/2022
• Initial Report FDA Received Date: 06/15/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 15 KG