MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE OXYGEN TUBING 7 FEET (2.1 M) CRUSH RESISTANT OXYGEN TUBING, VINYL TIPPED; CANNULA, NASAL, OXYGEN

Model Number	AIRLIFE OXYGEN TUBING 7 FEET (2.1 M) CRUSH RESISTANT OXYGEN TUBING, VINYL TIPPED
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer stated that the samples are not available for evaluation and no photos were taken.Additionally, lot number was not provided; device history record (dhr) could not be performed.At this point, there's not enough information to reach root cause.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 airlife oxygen tubing 7' (2.1m) crush resistant oxygen tubing, vinyl tipped keeps getting disconnected from the hose nipple of the flowmeter while connected to the patient via bag valve mask.The end user had to pick up the end of the tubing and reattach it to the nipple hose before it can be used.At this time, there is no information regarding patient harm associated with the reported event.

• Brand Name: AIRLIFE OXYGEN TUBING 7 FEET (2.1 M) CRUSH RESISTANT OXYGEN TUBING, VINYL TIPPED
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10155971
• Report Number: 8030673-2020-00099
• Device Sequence Number: 13963730
• Product Code: CAT
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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: AIRLIFE OXYGEN TUBING 7 FEET (2.1 M) CRUSH RESISTANT OXYGEN TUBING, VINYL TIPPED
• Device Catalogue Number: 001302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/15/2020
• 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