MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - MEXICALI; CHEST TUBE TRAY

Catalog Number	DYNDA2892B
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, "the locking mechanism on the chest tube fell off and opened at the slightest touch, causing an air leak.The air leak was repaired with vaseline gauze and tegaderm, but we were unable to place the alteplase and dornase as ordered." no reported serious injury.The product has been requested for evaluation.No additional information at this time.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
According to the facility, on (b)(6) 2025, "the locking mechanism on the chest tube fell off and opened at the slightest touch, causing an air leak.The air leak was repaired with vaseline gauze and tegaderm, but we were unable to place the alteplase and dornase as ordered.".

• Common Device Name: CHEST TUBE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - MEXICALI; calle circuito del desierto #7; parque industrial del desierto; mexicali baja california, 21383 ; MX 21383
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 22817545
• Report Number: 3015173212-2025-00002
• Device Sequence Number: 18318727
• Product Code: FTN
• UDI-Device Identifier: 10195327348441
• UDI-Public: 10195327348441
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/15/2025

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: DYNDA2892B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/15/2025
• 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 Age: 32 YR
• Patient Sex: Male