MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATH, CLOSED SUCTION, 14FR, DBL SWL, ETT

Catalog Number	DYNCSDS14
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Hypoxia (1918); Increased Respiratory Rate (2486); Respiratory Insufficiency (4462)
Date of Event	09/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on 09/07/2024 the suction catheter would "not stay locked in the off position" causing a "sudden loss of delivered tidal volume with increased rr and drop in spo2" on a patient receiving mechanical ventilation.
Additional Manufacturer Narrative
According to the customer, on 09/07/2024 the suction catheter would "not stay locked in the off position" causing a "sudden loss of delivered tidal volume with increased rr and drop in spo2" on a patient receiving mechanical ventilation.The customer reported the circuit, endotracheal tube, ventilator, and in-line suction catheter were changed "with no improvement".The customer reported patient was sent to "ct" for "further evaluation" and the ventilator settings were "adjusted to compensate".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.Lots retained for investigation from customer: 28623040004, 28623040008, 28623070004, 28623080005, 28623090005, 28624020016.

• Common Device Name: CATH, CLOSED SUCTION, 14FR, DBL SWL, ETT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 20407581
• Report Number: 1417592-2024-00893
• Device Sequence Number: 15082612
• Product Code: BSY
• UDI-Device Identifier: 40884389125060
• UDI-Public: 40884389125060
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 10/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNCSDS14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/09/2024
• 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: Male