MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CANISTER, RIGID, 2000CC

Catalog Number	OR220
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Hypoxia (1918)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6)2025 when attempting to suction the patient's vomit during intubation, they were "unable to suction emesis", the patient aspirated, and "developed severe hypoxemia followed by pea arrest".
Additional Manufacturer Narrative
According to the customer, on (b)(6)2025 when attempting to suction the patient's vomit during intubation, they were "unable to suction emesis", the patient aspirated, and "developed severe hypoxemia followed by pea arrest".The customer reported "the suction canister lids" are not creating a "vacuum", but there is no identifiable cracks or deformities.The customer reported after the "suction canister lids were changed" the suction system was "able to function properly".The customer reported the patient died after the incident occurred.No additional information is available at this time.It has been determined that the reported event caused or contributed to death, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: CANISTER, RIGID, 2000CC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21712460
• Report Number: 1417592-2025-00145
• Device Sequence Number: 21320205
• Product Code: KDQ
• UDI-Device Identifier: 10888277363359
• UDI-Public: 10888277363359
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 03/27/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: OR220
• Device Lot Number: 68124106808C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 54 YR
• Patient Sex: Female