MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC

Catalog Number	HUDRHO41U
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, they are having issues with the tubing disconnecting from the masks after they come out of surgery into the pacu setting.The patients aren't receiving any oxygen, causing their oxygen saturation to drop and causes them to inhale excess co2 from the mask.Per the facility, there has been no serious injury related to this because the nurse is right there to catch it and fix it.They replace the oxygen masks.No additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, they are having issues with the tubing disconnecting from the masks after they come out of surgery into the pacu setting.
Additional Manufacturer Narrative
Updated h3: device evaluated by manufacturer.Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).

• Common Device Name: MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23696414
• Report Number: 1417592-2025-00678
• Device Sequence Number: 9193257
• Product Code: BYG
• UDI-Device Identifier: 10197344010646
• UDI-Public: 10197344010646
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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 Catalogue Number: HUDRHO41U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown