MAUDE Adverse Event Report: VYAIRE MEDICAL BROSELOW WHITE INTUBATION MODULE; EMERGENCY RESPONSE SAFETY KIT

Model Number	BROSELOW WHITE INTUBATION MODULE
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that during the resuscitation of a patient, the broselow, intubation mod, white, 2pk was cracked by an er staff> upon inspection the device had a missing male end to attach the wall suction to the ng.The customer confirmed no harm was done to the patient but had a delay in decompression because of looking for a replacement.
Additional Manufacturer Narrative
At this time, the suspect device was not returned for evaluation because there was no damaged on the product but only has a missing male end.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Device evaluation:g3,g6,h2, and h10.Result of investigation:the suspect device was not available for evaluation.However, the reported lot number 0004129376 identified that the ng tube the customer reported in the complaint is the subassembly part number r7710nga (used for the manufacture of the fg 770win).Due to a supplier change under (b)(4), all the products manufactured after october 2019 would not come with the male end adapter, for this reason the ng tube did not come with the male end adapter since the reported lot number was manufactured on 12mar2020.Therefore, the defect reported by the customer was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: BROSELOW WHITE INTUBATION MODULE
• 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 n; o. 85, parque undustrial mexic; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 15916755
• Report Number: 8030673-2022-00282
• Device Sequence Number: 6564063
• Product Code: OKI
• UDI-Device Identifier: 10885403423550
• UDI-Public: (01)10885403423550(10)0004129376
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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: BROSELOW WHITE INTUBATION MODULE
• Device Catalogue Number: 7700WIN
• Device Lot Number: 0004129376
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Sex: Unknown