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

Model Number INFANT FLOW LP NASAL PRONGS,SMALL

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 296698937
• Report Number: 8030673-2022-00232
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 50846446004593
• UDI-Public: (01)50846446004593
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1