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

Catalog Number	DYNCSDS14T
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the customer contact that the "device can not be disconnected".It was reported that this caused the "adapter dislodge from the endotracheal tube causing patient to be disconnected from the ventilator".Due to this, the endotracheal tube had to be exchanged.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.
Event or Problem Description
"device can not be disconnected".
Additional Manufacturer Narrative
Sample information added.

• Common Device Name: CATH, CLOSED SUCTION, 14FR,DBL SWL,TRACH
• 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: 19020308
• Report Number: 1417592-2024-00456
• Device Sequence Number: 14423152
• Product Code: BSY
• UDI-Device Identifier: 10884389145883
• UDI-Public: 10884389145883
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 04/02/2024

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: DYNCSDS14T
• Device Lot Number: 28623100004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 06/26/2024
• 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