MAUDE Adverse Event Report: Medline; 14 FR DOUBLE SWIVEL CLOSED SUCTION

Model Number	DYNCSDS14
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	09/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient that was on a ventilator lost their tidal volume and their oxygen saturation dropped.The reporter stated that the patient had to be manually bagged while back up was called to short self-test (sst) the ventilator and make sure there was not an issue with the ventilator.The doctor reportedly used the glide scope to check the placement of the tube and cuff.The ventilator passed the sst so the suction catheter was removed and the problem was resolved.After changing out the suction catheter the patient returned to getting their full tidal volume.No additional information is available.There is no sample available to return to the manufacturer for evaluation.
Event or Problem Description
It was reported that a patient that was on a ventilator lost their tidal volume and their oxygen saturation dropped requiring the suction catheter to be replaced to resolve the issue.

• Brand Name: Medline
• Common Device Name: 14 FR DOUBLE SWIVEL CLOSED SUCTION
• MDR Report Key: 12651750
• Report Number: 1417592-2021-00194
• Device Sequence Number: 19955533
• Product Code: BSY
• UDI-Device Identifier: 10884389125069
• UDI-Public: 10884389125069
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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: DYNCSDS14
• Device Catalogue Number: DYNCSDS14H
• Device Lot Number: 28620100007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention