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

Model Number	67P030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot number, expiration date and h4: manufacture date are 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 required.
Event or Problem Description
Patient received new trach at about 1800 and some agitation and bloody suctioning of the trach was noted, though patient was reported to be asleep at shift change.Patient woke up at 2100 and was noted to be agitated with no left sided breath sounds.Until 2230 increased work of breathing, mottled, blue, emesis and still no breath sounds on left side was reported.Multiple providers called to bedside on for interventions.Interventions included fi02 to 100%, cpt, bagging, reposition and change of trach ties, x-ray, tylenol, continued assessment of breath sounds/vitals/suctioning (bright red).Patient did not improve and so a trach change was carried out.Once removed, it was noted that the cuff was only filling up on the left side and therefore occluding oxygenation to the left lung of the patient.
Additional Manufacturer Narrative
Device evaluation: one used, decontaminated device was received for investigation.Visual inspection noted the unit was returned without its obturator; no damage or dysfunctional conditions that could affect the cuff performance were observed.The reported failure mode, cuff not symmetric, could not be confirmed during functional testing.A device history report (dhr) review could not be completed as no lot number was provided.The item number 67p030 was reported however it was noted that the item number of the received device was 67nfps30.No corrective actions are required.This failure will continue to be monitored to determine if new actions need to be taken.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB
• 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: 16845896
• Report Number: 3012307300-2023-04829
• Device Sequence Number: 6870604
• Product Code: JOH
• UDI-Device Identifier: 15021312006254
• UDI-Public: 15021312006254
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• 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): 06/20/2023

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: 67P030
• Device Catalogue Number: 67P030
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/01/2023
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/20/2023
• 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: Required Intervention
• Patient Age: 8 MO
• Patient Sex: Male