MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ ADULT ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number ANES CIRCUIT, ADULT, 108 IN EXP, 2L BAG

Device Problem Complete Blockage (1094)

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

Event Date 08/13/2023

Event Type  malfunction  

Manufacturer Narrative

H3: 81 other ¿ 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.

Event Description

It was reported to vyaire medical that the y-piece of a1uxoxxx anes circuit, adult, 108 in exp, 2l bag is blocked.Ventilation for the patient was not possible.The patient was initially spontaneously breathing and was also kept that way during the search for the cause.After ruling out any problem on the patient's side manual ventilation was performed on the patient via anesthesia bag.Only after changing the breathing circuit on the primus that the ventilation worked properly.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h3, h6 and h10 result of investigation: based on the investigation and since customer sent one physical sample of fg part number a1uxoxxx with lot number unknown for the investigation.The component wye adult plain bivona part number 070-215132a (used for the manufacture of fg part number a1uxoxxx) was functionally inspected by quality personal from extrusion area according to pqas 070-0005097a etal performing an occlusion test finding component occluded.Upon investigation it was found that cavity #4 of the mold (cavity used for the manufacture of component part number 070-215132a from the physical sample sent by customer) used for the manufacture of component part number 070-215132a had reports of mal functions due to wear on the mold's components.Based on this, equipment may be have contributed with the reported defect 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: VITAL SIGNS¿ ADULT ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17819223
• MDR Text Key: 324284338
• Report Number: 8030673-2023-00351
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752119215
• UDI-Public: (01)10190752119215(11)20220422(10)0004217210
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANES CIRCUIT, ADULT, 108 IN EXP, 2L BAG
• Device Catalogue Number: A1UXOXXX
• Device Lot Number: 0004217210
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 21 YR