MAUDE Adverse Event Report: VYAIRE MEDICAL LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; ANESTHESIA CIRCUITS AND ACCESSORIES

Model Number LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported the product sample and photo is available for analysis.At this time, vyaire has not received the suspect device for evaluation.Any additional information provided by the customer will be included in a follow-up report.

Event Description

The customer reported a leak on the limb-o breathing circuit.The event occurred while connected to a patient.The customer reported that they had replaced the circuit to prevent patient harm; and due to the change of the device, the treatment was delayed.The customer confirmed that no patient harm was associated on this event.

Manufacturer Narrative

Device evaluation: d4, d10, g4, g7, h2, h3, h6 and h10.Result of investigation: investigation traced the reported event to be due to manufacturing as the hole in the tube can be caused by improperly assembled gaylord boxes for storage, sharp or hard edges of the extrusion/assembly equipments, and leak tester machine which detects a faulty circuit but does not remove it from the assembly line.

• Brand Name: LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Type of Device: ANESTHESIA CIRCUITS AND ACCESSORIES
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9484727
• MDR Text Key: 188117031
• Report Number: 8030673-2019-00055
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: AFNXXXXX
• Device Lot Number: 0004042556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR