MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE REDUCED HEPARIN ARTERIAL BLOOD SAMPLER; QUICK ABG SAMPLER

Model Number AIRLIFE REDUCED HEPARIN ARTERIAL BLOOD SAMPLER

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

As of this time device has not been returned for evaluation.There are three available lot numbers affected: 0004031880, 0004051261, 0004056172.The customer reported that they have 5 affected samples but 10 samples will be returned.These 10 samples are all lot number 0004051261.Any additional information received from the customer will be included in a follow-up report.Pma/510(k): enforcement discretion.

Event Description

The customer reported five airlife reduced heparin arterial blood sampler were used in the ed where the blood had coagulated before the abg could be processed.All five tests had to be redone.No patient harm was reported.

• Brand Name: AIRLIFE REDUCED HEPARIN ARTERIAL BLOOD SAMPLER
• Type of Device: QUICK ABG SAMPLER
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; 85 parque undustrial mex iii; mexicali, 21397 ; MX 21397
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, IL 60045
• MDR Report Key: 9766317
• MDR Text Key: 206392729
• Report Number: 8030673-2020-00078
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE REDUCED HEPARIN ARTERIAL BLOOD SAMPLER
• Device Catalogue Number: 4022400
• Device Lot Number: 0004031880, 0004051261
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1