MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATH,CLOSED SUCTION,14FR,T-PC,TRACH

Catalog Number	DYNCSTP14T
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 the patient was "deteriorating medically" and "experienced hypoxia" due to the closed suction "continually suctioning as if the thumb valve was engaged".The customer reported the patient experienced "loss of tidal volume" and the vent was "adjusted", but there was "no change".The customer reported that the "thumb drive was not in the lock position".The customer reported when the closed suction was removed the "tidal volume returned to prescribed settings" and "the patient recovered".The customer did not report any serious injury related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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
According to the customer, on (b)(6) 2024 the patient was "deteriorating medically" and "experienced hypoxia" due to the closed suction "continually suctioning as if the thumb valve was engaged".

• Common Device Name: CATH,CLOSED SUCTION,14FR,T-PC,TRACH
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 20033759
• Report Number: 1417592-2024-00818
• Device Sequence Number: 20434264
• Product Code: BSY
• UDI-Device Identifier: 40884389145983
• UDI-Public: 40884389145983
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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: DYNCSTP14T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/22/2024
• 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: Unknown