MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. RESOLVE LOCKING DRAINAGE CATHETER

Catalog Number	RLC-12-038MB/C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that when locking the catheter, the side white wall came off on the catheter.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.A visual examination of the device revealed that the cap has been damaged leaving a portion inside the connection point with the hub of the catheter.The root cause of the defect could not be determined as the device has been opened and the device appears to have broken causing the pieces to separate.The device history record was reviewed, and no exception documents were found.

• Brand Name: RESOLVE LOCKING DRAINAGE CATHETER
• Common Device Name: LOCKING DRAINAGE CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan, ut 84095 ; MX 84095
• Manufacturer Contact: adrian cole ; 1600 west merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 22384445
• Report Number: 1721504-2025-00136
• Device Sequence Number: 12952126
• Product Code: GBX
• UDI-Device Identifier: 00884450580639
• UDI-Public: 00884450580639
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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 Catalogue Number: RLC-12-038MB/C
• Device Lot Number: I3098263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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