MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE TRI-FLO SUCTION CATHETER WITH CONTROL PORT; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	CATHETER SUCT PH CONT 10FR TRI-FLO STRT
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the peelable packaging of t261c - catheter suct ph cont 10fr tri-flo strt was difficult to open because line of sealant too close to the end of the packaging which prevents the two laminated papers from being separated (bottom and top of the packaging).Also, when the time to use the product is much too long because it is often used in the emergency room, there is a risk of increased contamination for sterile suction.The customer confirmed that there was no patient harm/injury associated with the reported event.
Additional Manufacturer Narrative
H3: 81 other - 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
Device evaluation: g3, g6, h2, h3, h6 and h10.No pictures were provided.However, one opened physical sample of lot number 0004235908 was returned for evaluation.The physical sample was visually inspected, and no defect was found.Also, device history record was reviewed, and no issues were found.Root cause of the problem is not confirmed.

• Brand Name: AIRLIFE TRI-FLO SUCTION CATHETER WITH CONTROL PORT
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• 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 ; 2402760001
• MDR Report Key: 17419658
• Report Number: 8030673-2023-00338
• Device Sequence Number: 7134684
• Product Code: BSY
• UDI-Device Identifier: 10190752145511
• UDI-Public: (01)10190752145511(10)0004235908
• 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
• Report Date (Section B): 07/28/2023

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 PH CONT 10FR TRI-FLO STRT
• Device Catalogue Number: T261C
• Device Lot Number: 0004235908
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/18/2023
• 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