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

Model Number	AIRLIFE® ARTERIAL BLOOD SAMPLER
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the product sample and photo is available for analysis.At this time, vyaire has not received the suspect device for evaluation.Any additional information provided by the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that during the arterial sampling, the blood does not rise as usual but there is a draught with bubbles, there is blood dripping from the syringe when aspirating, and also, the tip of the syringe, which usually fits the opti cassette perfectly, is now too thin, so the syringe doesn't fit well on the cassette.There was no patient harm.
Additional Manufacturer Narrative
Additional information: g3, g6, h2, h3, h6, and h10.Result of investigation:the device history record (dhr) review did not show any deviations to manufacturer specifications.For functionality failure, it is imperative to receive a sample to duplicate the failure as described.The sample device has been discarded and not available for analysis.Additionally, the customer confirmed that no photo was available.Therefore, no investigation can be performed and the defect could not be confirmed.And the root cause of failure could not be determined.
Additional Manufacturer Narrative
H10: all the device history records from sub-assemblies were reviewed in order to detect any issue related to the defect reported by the customer during its manufacturing.All lots were manufactured per our internal procedures and no issues were found.Vyaire medical recived 74 closed samples of the p/n 9025eu for evaluation.A visual inspection was performed and found 20 samples with thread larger, 24 samples with silicon excess, 30 samples no issues were found.According to the investigation, personnel is related to the reported defect, as they must remove the silicon excess into barrel according to our internal procedure spm 601w etal.In addition, we currently do not have a specification to perform a full-time test so we are unable to perform a full-time test.According to our procedures, we only perform a leak test to verify that there is no leak between the plunger and the barrel.A root cause for the issue ""cannot draw or slow fill"" could not be determined.Although the root cause was not determined, a capa-000000878 was initiated to perform an investigation looking for fill issues and obtain the proper preventive and corrective actions.

• Brand Name: AIRLIFE® ARTERIAL BLOOD SAMPLER
• Common Device Name: ARTERIAL BLOOD SAMPLING KIT
• MDR Report Key: 12136053
• Report Number: 8030673-2021-00174
• Device Sequence Number: 11603450
• Product Code: CBT
• UDI-Device Identifier: 10190752155084
• UDI-Public: (01)10190752155084(10)4168152
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2021

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: 4168152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/06/2021; 08/18/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/30/2021; 08/23/2021
• 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