MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - SINGAPORE RESOLVE® LOCKING DRAINAGE.; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Catalog Number	RLC-8-038MB/C
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that the outside hub of the resolve locking drainage catheter broke/detached after placement.The catheters were placed for ascites and nephrostomy fluid drainage.A new drainage catheter was placed for this patient.The device is expected to return for a full engineering evaluation.
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 search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: RESOLVE® LOCKING DRAINAGE.
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21990152
• Report Number: 3011642792-2025-00065
• Device Sequence Number: 8388858
• Product Code: DXN
• UDI-Device Identifier: 00884450580714
• UDI-Public: 884450580714
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: RLC-8-038MB/C
• Device Lot Number: I3085041
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown