MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. CATHETER SUCT COIL 5-6FR CONT GRAD 50/CS; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	CATHETER SUCT COIL 5-6FR CONT GRAD 50/CS
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical the end of the t63c catheter suct coil 5-6fr cont grad 50/cs does not snuggly fit into suction tubing - there is no longer a ribbed connection and the customer was unable to get efficient seal to reach set suction pressures.It was used on a patient, but there is no harm reported.
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.
Additional Manufacturer Narrative
Results of investigation: vyaire medical investigatated the reported issue with the pictures provided of the fg 5/6fr.Suct.Cathet.S.Looped w/c part number t63c, showing a close-up of the subassembly body,6fr.Suction catheter part number 65-1910c however, it does not clearly show the failure.The device history record was reviewed and no issues were found.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 update: g3, g6, h2, h3, h6 and h10.Results of investigation: the customer sent pictures of the fg 5/6fr.Suct.Cathet.S.Looped w/c part number t63c, showing a close-up of the subassembly body,6fr.Suction catheter part number 65-1910c.The defect could not be identified in the picture provided.Customer also sent one opened decontaminated physical sample of the fg 5/6fr.Suct.Cathet.S.Looped w/c part number t63c with lot number 0004206274, physical sample was visually inspected, and no visual defects were found on the sample.In addition, the subassembly 6fr.Suction catheter part number 65-1910c was dimensionally inspected in order to assure that the outer diameter involved on the loose connection reported is within specification.Inspection was performed and dimension resulted acceptable, no issues were found with the subassembly involved.Therefore, we could not confirm the defect reported by the customer.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: CATHETER SUCT COIL 5-6FR CONT GRAD 50/CS
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 510 technology dr; irvine CA
• 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: 16525264
• Report Number: 8030673-2023-00301
• Device Sequence Number: 12073799
• Product Code: BSY
• UDI-Device Identifier: 10190752145559
• UDI-Public: (01)10190752145559(10)0004206274
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2023

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: CATHETER SUCT COIL 5-6FR CONT GRAD 50/CS
• Device Catalogue Number: T63C
• Device Lot Number: 0004206274
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 04/24/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/04/2023; 05/15/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown