MAUDE Adverse Event Report: VYAIRE MEDICAL BROSELOW YELLOW INTUBATION MODULE 2PK; EMERGENCY RESPONSE SAFETY KIT

Model Number	BROSELOW YELLOW INTUBATION MODULE 2PK
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the broselow yellow intubation module 2pk contains an adult size stylet (10fr) that is too big for the pediatric endotracheal tubes that can cause a deadly outcome.Furthermore, there is no patient associated with the said event.
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).H3: 81 other ¿ the customer did not send physical sample or pictures so the reported defect could not be confirmed.The physical sample and/or pictures are required as evidence to perform a better investigation about customer's reported defect.The device history record was reviewed and there were no issues during its manufacturing.The fg was sent with the small adult stylette 10 fr as indicated on our bom (bill of materials).Therefore, the root cause was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device was not returned.

• Brand Name: BROSELOW YELLOW INTUBATION MODULE 2PK
• Common Device Name: EMERGENCY RESPONSE SAFETY KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. 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 mexi; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17172588
• Report Number: 8030673-2023-00330
• Device Sequence Number: 7032420
• Product Code: OKI
• UDI-Device Identifier: 10885403423567
• UDI-Public: (01)10885403423567(10)0004115003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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: BROSELOW YELLOW INTUBATION MODULE 2PK
• Device Catalogue Number: 7700YIN
• Device Lot Number: 0004115003
• 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: 06/01/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown