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
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11069599
• Report Number: 8030673-2020-00136
• Device Sequence Number: 11590972
• Product Code: BYX
• UDI-Device Identifier: 10190752116603
• UDI-Public: (01)10190752116603
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention