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

Model Number	AIRLIFE® ARTERIAL BLOOD SAMPLER
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has not returned for evaluation yet.Department secluded 34 units of affected product lots to be returned.Any additional information received from the customer will be included in a follow-up report.Pma/510(k): enforcement discretion.
Event or Problem Description
The customer reported that the 9025tru 1ml syringe 25g 5/8" when inserting into patient's arm, needle detaches from the syringe.Unknown patient harm reported as of now.

• 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: 9777489
• Report Number: 8030673-2020-00080
• Device Sequence Number: 1431894
• Product Code: CBT
• UDI-Device Identifier: 10190752155817
• UDI-Public: (01)10190752155817(10)0004101521
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1