MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG

Device Problem Complete Blockage (1094)

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

Event Date 09/14/2022

Event Type  Injury  

Event Description

The customer reported to vyaire medical that while the patient is intubated the anes circuit, adult, 72 in limbo, 3l bag had a plastic barrier which prevented the oxygen from entering the corrugated tube.Alternative ventilation was provided and the customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

Result of investigation:the suspect device and photo was visually inspected by quality personnel according to pqas afm1qxxx etal identifying the component part number 65-20009 occluded with a plastic barrier at one of the component's end.It was determined that process may be related with the reported defect since in the procedure, is not indicated that the mold has to go down for cleaning after a time of permanence of plastic inside the mold due to a blackout or problem in machine that may have obstructed the flow of plastic to one of the cavities near the affected one, causing it to over pack.Therefore the root cause was determined.

• Brand Name: VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada v?a 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: 15609746
• MDR Text Key: 301814868
• Report Number: 8030673-2022-00274
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752121973
• UDI-Public: (01)10190752121973(10)0004213080
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG
• Device Catalogue Number: AFNX1900
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention