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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE REDUCED HEPARIN ARTERIAL BLOOD SAMPLER; MICRO ABG SAMPLER
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VYAIRE MEDICAL AIRLIFE REDUCED HEPARIN ARTERIAL BLOOD SAMPLER; MICRO ABG SAMPLER Back to Search Results
Model Number AIRLIFE® REDUCED HEPARIN ARTERIAL BLOOD SAMPLER
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2020
Event Type  malfunction  
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.Pma/ 510(k): enforcement discretion.
 
Event Description
The customer reported that the airlife® reduced heparin arterial blood sampler experienced leak issue.The customer confirmed that there was no patient harm associated with the reported event.
 
Manufacturer Narrative
Result of investigation: samples were received for evaluation.Samples were inspected, performed the string leak test and it was observed that the samples are acceptable.In addition the device history record was reviewed to confirm the use of the correct heparin and no issues were found.Therefore the defect reported by the customer was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
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Brand Name
AIRLIFE REDUCED HEPARIN ARTERIAL BLOOD SAMPLER
Type of Device
MICRO ABG SAMPLER
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key10848846
MDR Text Key218241355
Report Number8030673-2020-00128
Device Sequence Number1
Product Code CBT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAIRLIFE® REDUCED HEPARIN ARTERIAL BLOOD SAMPLER
Device Catalogue Number9025RHTR
Device Lot Number0004121342
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2020
Date Manufacturer Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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