MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW LP NASAL PRONGS,SMALL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	INFANT FLOW LP NASAL PRONGS,SMALL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed in order to detect any issue related with the reported defect during its manufacturing.The complete lot was manufactured, inspected and released per our internal procedures and no issues were found.And based on the investigation and per picture sent by the customer we could determined that the material is related with the reported defect since the part number cf60-101b prong, small, lp is not manufactured in vyaire mexicali.Although incoming inspection personnel perform an inspection according to rmqas 60-637 etal looking for regulatory defects, cosmetic defects, dimensional defects, this inspection is only a sampling.Therefore, the root cause was determined.In addition pfmea 09c was reviewed and we have the controls for this kind of issues.As a resolution, corrective and preventive actions will be provided in the scar (b)(4).Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the patient was on cpap and it must be changed from prong to mask.As they take the prong off, the part that goes into one of the nostrils falls off.There is no definite consequence reported for the patient.

• Brand Name: INFANT FLOW LP NASAL PRONGS,SMALL
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13653153
• Report Number: 8030673-2022-00232
• Device Sequence Number: 14945841
• Product Code: BZD
• UDI-Device Identifier: 50846446004593
• UDI-Public: (01)50846446004593
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K031745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

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: INFANT FLOW LP NASAL PRONGS,SMALL
• Device Catalogue Number: 777000S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown