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

Model Number	AIRLIFE® ARTERIAL BLOOD SAMPLER
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2021
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.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 plunger in the syringe is not working.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Result of investigation: samples were inspected visually and no issues were found, also samples were functionally inspected by performing a leak test and it was found that a sample was not filled during this test.Therefore the defect reported by the customer was confirmed.

• Brand Name: AIRLIFE ARTERIAL BLOOD SAMPLER
• Common Device Name: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11816349
• Report Number: 8030673-2021-00165
• Device Sequence Number: 3748156
• Product Code: OFP
• UDI-Device Identifier: 10190752155084
• UDI-Public: (01)10190752155084(10)0004165763
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 0004165763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1