MAUDE Adverse Event Report: VYAIRE MEDICAL CATHETER SUCT W/CONTROL 10FR 50/CS; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	CATHETER SUCT W/CONTROL 10FR 50/CS
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr - 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.Device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the airlife tri-flo suction catheter's tip appears to be cut instead of rounded look.The issue occurred during patient's dental case.The doctor used a bronchoscopy to look into both sides of the lungs, checked a chest x-ray and nothing abnormal was found.It was determined that it was broken before surgery.Furthermore, there is no harm done to the patient.
Additional Manufacturer Narrative
Result of investigation - the suspect device returned for further evaluation.The device history record was reviewed in order to detect any issue related to the reported defect during its manufacturing.Based on the investigation and per picture and physical sample provided by the customer in which we can identify the subassembly is damaged on the tip of the tubing.The manufacturing personnel may be related with the reported defect since if they do not properly follow the instruction referred to the proper way to insert the tubes into the tip and hole forming equipment, defects such as the one reported on this complaint may occur.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: CATHETER SUCT W/CONTROL 10FR 50/CS
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16718914
• Report Number: 8030673-2023-00311
• Device Sequence Number: 7347085
• Product Code: BSY
• UDI-Device Identifier: 10190752145542
• UDI-Public: (01)10190752145542(10)0004214265
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: CATHETER SUCT W/CONTROL 10FR 50/CS
• Device Catalogue Number: T61C
• Device Lot Number: 0004214265
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/08/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male