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

Catalog Number	4992209
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that post procedure of a right pleural catheter, the left catheter cap became dislodged allowing pleural fluid to drain and air to backflow into the catheter.This event caused a left-sided pneumothorax requiring hospitalization.No additional information available.
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.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• 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: 18466551
• Report Number: 3011642792-2024-00004
• Device Sequence Number: 16922878
• Product Code: DWM
• UDI-Device Identifier: 10801741091145
• UDI-Public: 10801741091145
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K110409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 01/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4992209
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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