MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CANISTER, RIGID, 1200CC

Catalog Number	OR212
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Choking (2464)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient was undergoing a procedure, "suction yankauer had been set up in advance as a precaution and was being used to remove residual and aspirated barium with patient assisting, but it stopped working and patient continued coughing.It was reported "it was discovered that the suction line had to be attached to the ortho hole rather than the vacuum hole which is standard.This delayed the patient receiving care while in distress.Patient suctioned after that and was stable and speaking to clinician before being sent back to his room".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
Suction stopped working.

• Common Device Name: CANISTER, RIGID, 1200CC
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20625448
• Report Number: 1417592-2024-00945
• Device Sequence Number: 7353535
• Product Code: KDQ
• UDI-Device Identifier: 40888277363343
• UDI-Public: 40888277363343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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
• Device Catalogue Number: OR212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/06/2024
• 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 Sex: Unknown