MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; LINER,SEMI-RIGID,3000CC,50EA/CS

Catalog Number	OR530
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/01/2024
Type of Reportable Event	Death
Event or Problem Description
A notification was received from medline france regarding an adverse event associated with or530.It was reported by the user facility that during a medical emergency, suction of the airway was required in order to intubate the patient, however the walled suction unit was not set up ready to use and when set up, it did not work correctly.
Additional Manufacturer Narrative
A notification was received from medline france regarding an adverse event associated with or530.It was reported by the user facility that during a medical emergency, suction of the airway was required in order to intubate the patient, however the walled suction unit was not set up ready to use and when set up, it did not work correctly.Per the facility immediate action was taken to use the cardiac arrest trolley to minimize the delay in providing emergency suction.According to the facility during an internal investigation after the event, it was found that a 3 liter liner had been placed inside the 1.5 liter cannister which resulted in the suction unit not working correctly.The customer reported that the patient has died, but the death is not related to the reported event.Reportedly, use error may have caused or contributed to the reported device problem/issue.No additional information is available at this time.No sample for return and evaluation was indicated.Due to the reported incident and patient death, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: LINER,SEMI-RIGID,3000CC,50EA/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21286253
• Report Number: 1417592-2025-00050
• Device Sequence Number: 9529480
• Product Code: KDQ
• UDI-Device Identifier: 10884389968116
• UDI-Public: 10884389968116
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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: OR530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown