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

Model Number	AIRLIFE® ARTERIAL BLOOD SAMPLER
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2020
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 an issue with abg kits.The luer lock threads attaching the needle to the safety catch oozes blood while obtaining an abg sample from an (b)(6) patient.At this time, there is no information regarding patient harm.
Additional Manufacturer Narrative
H10: the device history record review show no deviations to manufacturer specification.The sample was not returned for evaluation, however functional test was performed on the syringe with the same p/n 9025tru according to pqas 72-00001 etal to try to replicate the reported defect, noting that perhaps if the user, when removing the cap from the syringe, rotates it, it can loosen from the sure lock and cause the reported failure mode.Because no problems were identified in our processes a root cause of the problem was not determined.

• Brand Name: AIRLIFE® ARTERIAL BLOOD SAMPLER
• Common Device Name: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9741633
• Report Number: 8030673-2020-00074
• Device Sequence Number: 14081778
• Product Code: CBT
• UDI-Device Identifier: 10190752155817
• UDI-Public: (01)10190752155817(10)0004115370
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2020

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: 0004115370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1