MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS; STYLET, TRACHEAL TUBE

Model Number	S5000N
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that a five-hour old patient had an increased need of oxygen, and intubation was done with vital signs® endotracheal tube stylet used inside the tube.On retraction of the stylet, some of the plastic coating from the stylet remains inside the tube.The tube is immediately removed.The coating was found inside the tube and not in the lungs.The patient had to be sedated and intubated again.With achievement sufficient spontaneous respiration/improvement in condition, extubation was done, and the patient was placed on cpap (continuous positive airway pressure).The anaesthesia was extended from 10 min to 1.5 hours.To facilitate the sedation, bridion was given (a substance with which there is not much experience in children under 2 years of age).The incident is assessed as potentially serious.But did not have any serious consequences.The patient is fine and was discharged after a month of hospitalization with no signs of follow-up.
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However, the customer sent a picture which shows that a part of the component of the stylet, sheath s5000n is ripped off from the fg confirming the reported defect.The device history record with lot number 0004241036 was also reviewed as part of the investigation and no issues related with the reported defect were found.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
Additional Manufacturer Narrative
Result of the investigation: vyaire medical investigated the returned photo and device history record and based on the investigation of part number s5000n with lot number 0004241036 we can appreciate that a part of the component part number 070-10031 ripped off from the fg confirming the reported defect.However, this defect could not have happened inside our process.The defect was tried to be replicated but with no success.In the picture received we can appreciate stress caused by stretching the component part number 070-10031 from the fg part number s5000n, this might have been caused if the fg part number s5000n was stuck inside the endotracheal tube.We determined that the defect reported was caused by a misuse/improper handling of the product by the user and not by our internal process.
Additional Manufacturer Narrative
The information for d1 and d4 is being corrected since fda requested us to update the following fields.Upon their review, they have determined that the device identification information about the suspect medical device conflicts with the data submitted to global unique device identification database (gudid).The data data submitted to gudid must match the device identification data submitted for devices involved in mdr reportable events.D1:corrected brand name information.D4:corrected model #.

• Brand Name: VITAL SIGNS
• Common Device Name: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85,parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 18102423
• Report Number: 8030673-2023-00357
• Device Sequence Number: 5698358
• Product Code: BSR
• UDI-Device Identifier: 10190752145207
• UDI-Public: (01)10190752145207(10)0004241036
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2023

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: S5000N
• Device Catalogue Number: S5000N
• Device Lot Number: 0004241036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 12/01/2023; 05/30/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/19/2023; 05/31/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 1 KG