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

Catalog Number	4992207/A
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Merit medical received a patient experience report involving the aspira catheter.The patient reported that fluid drained slowly or not at all from a catheter located in the abdomen.No injury, serious injury, or medical intervention was reported.The event was initially submitted as a malfunction report.Upon further review and rerunning the fda reportability decision tree, merit medical determined that the reported issue would not cause or contribute to death or serious injury if the event were to recur.If slow or no drainage were to recur, the situation could be mitigated by repositioning, ensuring the drainage line and catheter are securely connected and not kinked, using a new drainage kit when appropriate, or contacting the healthcare provider for further instruction.Based on this reassessment, the event does not meet the reporting criteria under 21 cfr 803 because there was no death, serious injury, or reportable malfunction.Merit medical requests that this supplemental report supersede the initial submission and that the original mdr be considered non-reportable.
Event or Problem Description
No injury was reported.Supplemental report submitted to correct the initial report after reassessment determined the event is not reportable under 21 cfr part 803.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.A review of the device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.
Event or Problem Description
Patient experience report involving the aspira® product family included a report involving a male patient aged 18 years or older experienced slow to no drainage in the catheter.The catheter was located in the abdomen for drainage.

• Brand Name: ASPIRA®
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 25036455
• Report Number: 3011642792-2026-00063
• Device Sequence Number: 21092240
• Product Code: PNG
• UDI-Device Identifier: 00884450394878
• UDI-Public: 00884450394878
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2026

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
• Device Catalogue Number: 4992207/A
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male