MAUDE Adverse Event Report: VYAIRE MEDICAL TUBING 7FT O2 VINYL TIP CRUSH 50/CS; CANNULA, NASAL, OXYGEN

Model Number TUBING 7FT O2 VINYL TIP CRUSH 50/CS

Device Problem Connection Problem (2900)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.However, the customer is still asked for sample availability and lot number affected.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the tubing 7ft o2 vinyl tip crush 50/cs, during emergency, since the child who was bradycardic and desaturated needed to use the device.Upon opening the o2 manometer, the tubing became loose, thus delaying the intervention on the child.

Manufacturer Narrative

The suspect device and photos are not available for return, as it was discarded.Also, customer provided lot 0004088707.The device history record was reviewed in order to detect any issue related with this customer report, but no issues were found.No further evaluation can be completed at this time.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: TUBING 7FT O2 VINYL TIP CRUSH 50/CS
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11069599
• MDR Text Key: 223605736
• Report Number: 8030673-2020-00136
• Device Sequence Number: 1
• Product Code: BYX
• UDI-Device Identifier: 10190752116603
• UDI-Public: (01)10190752116603
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TUBING 7FT O2 VINYL TIP CRUSH 50/CS
• Device Catalogue Number: 001302
• Device Lot Number: 0004088707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention