MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO ASPIRA DRAINAGE CATHETER.; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number	4992209/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device will not be returning for engineering evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Event or Problem Description
The customer reports that when they hook up the adapters in the kit, the fluid would not drain.Physician used the repair kit to fix the drain issue.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be re-opened.

• Brand Name: ASPIRA DRAINAGE CATHETER.
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• 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 bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16587530
• Report Number: 3011642792-2023-00020
• Device Sequence Number: 4925837
• Product Code: PNG
• UDI-Device Identifier: 00884450394908
• UDI-Public: 884450394908
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K212675
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2024
• Device Catalogue Number: 4992209/A
• Device Lot Number: I2546597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 05/13/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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
• Patient Sex: Unknown