MAUDE Adverse Event Report: PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. CANNULA SOFT ADULT W/U-CON 7FT TB 50/CS; CONSERVER, OXYGEN

Model Number	CANNULA SOFT ADULT W/U-CON 7FT TB 50/CS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been 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
It was reported to vyaire medical that the sft2699 cannula soft adult w/u-con 7ft tb 50/cs cannula is looped so the patient just breathes in their own air.There is no information on the patient outcome.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h6 and h10.Vyaire determined that manufacturing personnel may be related with the reported defect since it was registered that new personnel was working on the line at the time the fg part number sft2699 was being manufactured.This bring us that new personnel may not have followed correctly the procedure according to spm 001309 etal on how to properly assembly the fg sft2699, however is and isolated case since we have not received any complaints about this issue in the past.In addition, pfmea-14a-005 was reviewed and we have controls for this type of issues.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: CANNULA SOFT ADULT W/U-CON 7FT TB 50/CS
• Common Device Name: CONSERVER, OXYGEN
• Manufacturer (Section D): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali,21397 ; MX
• 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: 16305622
• Report Number: 8030673-2023-00296
• Device Sequence Number: 6074735
• Product Code: NFB
• UDI-Device Identifier: 10190752117815
• UDI-Public: (01)10190752117815(10)0004232076
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: CANNULA SOFT ADULT W/U-CON 7FT TB 50/CS
• Device Catalogue Number: SFT2699
• Device Lot Number: 0004232076
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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