MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE® ARTERIAL BLOOD SAMPLER; ARTERIAL BLOOD SAMPLING KIT

Model Number	AIRLIFE® ARTERIAL BLOOD SAMPLER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Pma/ 510(k): enforcement discretion vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the airlife® arterial blood sampler experienced blood does not flow up the syringes as if there is additional back pressure.Blood is flashing in the hub then flowing back to the patient.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Result of investigation: sample provided for evaluation.Samples were inspected and were found with excess of silicon.Therefore, the defect reported by the customer could be confirmed.The root cause is determined to be manufacturing process - assembly process (internal).

• Brand Name: AIRLIFE® ARTERIAL BLOOD SAMPLER
• Common Device Name: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, ; MX
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12502521
• Report Number: 8030673-2021-00196
• Device Sequence Number: 17435431
• Product Code: CBT
• UDI-Device Identifier: 10190752155084
• UDI-Public: (01)10190752155084(10)0004165765
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: AIRLIFE® ARTERIAL BLOOD SAMPLER
• Device Catalogue Number: 9025TRU
• Device Lot Number: 0004165765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 11/19/2021
• 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