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

Model Number	VITAL SIGNS® ENDOTRACHEAL TUBE STYLET
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, vyaire has not received the suspect device/component for evaluation.Therefore, no root cause could be determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the vital signs endotracheal tube stylet was used on a baby and when the stylet was pulled out, the customer noticed that the sheath was separated from the stylet.The customer confirmed that there is no patient harm associated with this reported event.
Additional Manufacturer Narrative
Result of investigation: the device history record of the lot number reveals "bad cut in the end of stylet" during the manufacturing process, confirming the reported defect.Dhr indicated these corrective actions were performed at the colorado facility that is now closed: adjusted air pressure for slide cylinder and temperature offset and aligned fixture.

• Brand Name: VITAL SIGNS ENDOTRACHEAL TUBE STYLET
• Common Device Name: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10397035
• Report Number: 8030673-2020-00113
• Device Sequence Number: 14203139
• Product Code: BSR
• UDI-Device Identifier: 10190752145207
• UDI-Public: (01)10190752145207(10)11376918
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VITAL SIGNS® ENDOTRACHEAL TUBE STYLET
• Device Catalogue Number: S5000N
• Device Lot Number: 11376918
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 5 MO