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
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.
Additional Manufacturer Narrative
Other, other text: h4: device manufacturing date and d4: device expiration date could not be determined d4: device serial number/lot number is unknown h6: health effects - health impact: f27 h6: event problem and evaluation codes: update not required h10: no lot number was provided; therefore, device history record review could not be performed.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: e2: health professional: no; e3: occupation: non-healthcare professional; e4 is unknown, no information provided to date.

• 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14798746
• Report Number: 3012307300-2022-12437
• Device Sequence Number: 17669343
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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 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
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Life Threatening; Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 15 KG