MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO PLEURAL DRAINAGE STARTER KIT; APPARATUS, SUCTION DEVICE

Catalog Number	4992509/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during removal of the catheter, the polyester cuff came off.The removal required opening the area to allow for removal of the cuff followed by stitching up the area.No additional details to report.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.

• Brand Name: PLEURAL DRAINAGE STARTER KIT
• Common Device Name: APPARATUS, SUCTION DEVICE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 17680500
• Report Number: 3011642792-2023-00056
• Device Sequence Number: 7301932
• Product Code: DWM
• UDI-Device Identifier: 00884450394946
• UDI-Public: 884450394946
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K110409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 4992509/A
• Device Lot Number: I2387753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown