MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS® PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number INFUSOR, PRESSURE, 500 ML, NETTED, 12/CS

Device Problem Leak/Splash (1354)

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

Event Date 10/14/2022

Event Type  malfunction  

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.

Event Description

The customer reported to vyaire medical that the infusor, pressure, 500 ml, netted, 12/cs has an air leakage during patient's surgery.The customer confirmed no harm was done to the patient.

Manufacturer Narrative

Result of investigation:the suspect device lot number pass all the inspection requirement on function, visual, and packaging requirement.The complaint's air leakage was considered as supplier material issue of tpu film.Therefore, the defect reported by the customer was confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VITAL SIGNS® PRESSURE INFUSOR
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; qiao long district, tangxia; dongguan, 52373 0; CH 523730
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15774367
• MDR Text Key: 307885109
• Report Number: 3013421741-2022-00022
• Device Sequence Number: 1
• Product Code: KZD
• UDI-Device Identifier: 10190752133723
• UDI-Public: (01)10190752133723(10)222761
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFUSOR, PRESSURE, 500 ML, NETTED, 12/CS
• Device Catalogue Number: IN800012
• Device Lot Number: 222761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/01/2023
• 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