MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE® ARTERIAL BLOOD SAMPLER; ARTERIAL BLOOD GAS PRODUCTS (ABG)

Catalog Number 9425TRU

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

Vyaire medical has confirmed that the complaint sample is not available for evaluation.Without the sample to confirm the reported issue and find a root cause, vyaire has determined no corrective or preventative actions will be required at this time.

Event Description

The customer reported: the syringe and hub moved but the needle had become detached from both the hub and syringe.The needle was left inside the patients arm.Patient involved.

• Brand Name: AIRLIFE® ARTERIAL BLOOD SAMPLER
• Type of Device: ARTERIAL BLOOD GAS PRODUCTS (ABG)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; #85 parque undustrial; mexicali, 21397 ; MX 21397
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8848360
• MDR Text Key: 152917067
• Report Number: 8030673-2019-00048
• Device Sequence Number: 1
• Product Code: CBT
• Combination Product (y/n): N
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9425TRU
• Device Lot Number: 0004084211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• 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
• Patient Outcome(s): Required Intervention