MAUDE Adverse Event Report: PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG

Device Problem Disconnection (1171)

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

Event Date 07/11/2022

Event Type  Injury  

Event Description

It was reported to vyaire medical that the anes circuit, adult, 108 in exp, 3l bag disconnect from the wye while connected to a patient.The circuit was reconnected to the wye during the patient's procedure and no further actions were required.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

H11-corrected d3 to provide the correct manufacturer name.

• Brand Name: ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via 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: 15196260
• MDR Text Key: 297570629
• Report Number: 8030673-2022-00266
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10190752121171
• UDI-Public: (01)10190752121171(10)0004201314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
• Device Catalogue Number: A8UB20X4
• Device Lot Number: 4201314
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• 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