MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; OUTER CANISTER, SOFT LINER, 1500CC

Model Number	DYNDCLO1500
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Cardiac Arrest (1762); Respiratory Arrest (4461)
Date of Event	12/16/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that there was no suction from the device.
Additional Manufacturer Narrative
The user facility indicated that a patient of the surgery department was found on the ground in cardiorespiratory arrest following aspiration after vomiting.Reportedly, during resuscitation, there was no suction from the device "despite the verification of the connections" and no back up device was available.According to the user facility, the patient expired.Use error may have caused or contributed to the reported device problem/issue as it was indicated that the device was not in an upright and stable position at the time of the incident.No sample was returned for evaluation.No additional details are available at this time.Due to the reported incident and patient expiration, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

• Brand Name: Medline
• Common Device Name: OUTER CANISTER, SOFT LINER, 1500CC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 16786141
• Report Number: 1417592-2023-00179
• Device Sequence Number: 5436124
• Product Code: KDQ
• UDI-Device Identifier: 10884389129593
• UDI-Public: 10884389129593
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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 Model Number: DYNDCLO1500
• Device Catalogue Number: DYNDCLO1500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Death
• Patient Age: 82 YR
• Patient Sex: Unknown
• Patient Weight: 50 KG