MAUDE Adverse Event Report: VYAIRE MEDICAL NEO-VERSO 'Y' NEONATAL Y AIRWAY ACCESS ADAPTER; CLOSED SUCTION CATHETERS AND ADAPTORS

Model Number NEO-VERSO 'Y' NEONATAL Y AIRWAY ACCESS ADAPTER

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

The customer indicated that the suspected sample is available to return for investigation.At this time, the suspect device has not received yet.Investigation is still ongoing.Therefore, no root cause could be determine yet.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that the csc300 adapter verso airway sz2.0-4.0 et tubes's adapter has a crack in multiple places.This was seen during patient use and they replaced the device.No patient harm was reported.

• Brand Name: NEO-VERSO 'Y' NEONATAL Y AIRWAY ACCESS ADAPTER
• Type of Device: CLOSED SUCTION CATHETERS AND ADAPTORS
• 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 via de la produccion; 85 industrial mexicali; mexicali, 21397 ; MX 21397
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 9576447
• MDR Text Key: 188823016
• Report Number: 8030673-2020-00064
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEO-VERSO 'Y' NEONATAL Y AIRWAY ACCESS ADAPTER
• Device Catalogue Number: CSC300
• Device Lot Number: 201811230001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention