MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DYNDSCL1500

Catalog Number	DYNDSCL1500
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the suction liner "repeatedly" had little or no suction causing a patient to be "reanimated" as a result.
Additional Manufacturer Narrative
According to the customer, the suction liner "repeatedly" had little or no suction causing a patient to be "reanimated" as a result.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Update d9: returned to manufacturer.Update h3: device evaluated by manufacturer.Update h6: type of investigation.

• Common Device Name: DYNDSCL1500
• 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: 18015247
• Report Number: 1417592-2023-00428
• Device Sequence Number: 20479466
• Product Code: KDQ
• UDI-Device Identifier: 10884389129531
• UDI-Public: 10884389129531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 11/30/2023

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
• Device Lot Number: 670221026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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