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

Catalog Number	DYNDSCL1500
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, during the cardiac arrest of a patient on 10/25/2023 the suction "stopped" functioning at the beginning of treatment but, then began functioning "weakly".The customer reported there was a presence of "basal pneumonia probably linked to inhalation", the "scanner" showed a "pulmonary embolism", and the patient had a "pejorative neurological prognosis".The customer reported "aspiration occurred after the cardiac arrest of the patient".The customer reported the patient died the next day on 10/26/2023 following a no resuscitation agreement with the family.It has been determined that the reported event caused or contributed to death/serious injury, therefore, 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 customer, during the cardiac arrest of a patient on (b)(6) 2023 the suction "stopped" functioning at the beginning of treatment but, then began functioning "weakly".

• Common Device Name: LINER,SOFT,SUCTION CANISTER,1500CC
• 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: 18370275
• Report Number: 1417592-2023-00508
• Device Sequence Number: 18096858
• Product Code: KDQ
• UDI-Device Identifier: 10884389129531
• UDI-Public: 10884389129531
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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 Catalogue Number: DYNDSCL1500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/20/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown